API® 20 C AUX 20210Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 03573026048082), received between Oct 17, 2019 and Apr 27, 2022 — classified as 58 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (53 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 9, 2022Open, Classified

   As the temperature and time out of range was exceeded, product performances cannot be guaranteed

   Z-0785-2023 · Root cause: Storage · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2022Nonstandard Device; Nonstandard Device

  INTENDED USE: API® 20 C AUX IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE PRECISE IDENTIFICATION OF THE MOST FREQUENTLY ENCOUNTERED YEASTS. IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY ADAPTED DATABASE. INOCULATION AND READING OF THE STRIP ARE PERFORMED MANUALLY AND THE IDENTIFICATION IS OBTAINED USING AN IDENTIFICATION SOFTWARE. INCIDENT DESCRIPTION: A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX A STRIP ISSUE LEADING TO "NO RESULT" IN ASSOCIATION WITH THE PRODUCT API 20 C AUX 25 STRIPS+25MEDIA (REF 20210, BATCH NUMBER 1009159121, EXPIRY DATE 03-JUL-2023) WITH FOUR PATIENT'S STRAINS (OPHTHALMIC SAMPLES). THE CUSTOMER REPORTED AN ISSUE WITH ONE BATCH OF API 20C STRIPS WHERE THE CUPS DRIED OUT TOO QUICKLY. IT WAS REPORTED THAT THE LID DIDN'T CLOSE TIGHTLY BECAUSE IT WAS DEFORMED, BUT EVEN WHEN ADDING TAPE IT DRIED OUT AND THE WATER PUT UNDER THE STRIP EVAPORATED COMPLETELY. THE CUSTOMER PERFORMED AN ANTIFUNGIOGRAM WITHOUT HAVING THE IDENTIFICATION BECAUSE NO OTHER METHODS WERE AVAILABLE. PER PHOTOS SENT BY THE CUSTOMER, THE WATER IN THE HONEY-WELLS AND THE SUSPENSION INSIDE THE STRIPS WELLS ARE DEHYDRATED. CONSEQUENTLY, THE PROFILE CANNOT BE READ. IT WAS HIGHLIGHTED BY BIOMÉRIEUX G

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218306 ↗
• MalfunctionApr 27, 2022Nonstandard Device; Nonstandard Device

  INTENDED USE: API® 20 C AUX IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE PRECISE IDENTIFICATION OF THE MOST FREQUENTLY ENCOUNTERED YEASTS. IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY ADAPTED DATABASE. INOCULATION AND READING OF THE STRIP ARE PERFORMED MANUALLY AND THE IDENTIFICATION IS OBTAINED USING AN IDENTIFICATION SOFTWARE. INCIDENT DESCRIPTION: A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX A STRIP ISSUE LEADING TO "NO RESULT" IN ASSOCIATION WITH THE PRODUCT API 20 C AUX 25 STRIPS+25MEDIA (REF 20210, BATCH NUMBER 1009159121, EXPIRY DATE 03-JUL-2023) WITH FOUR PATIENT'S STRAINS (OPHTHALMIC SAMPLES). THE CUSTOMER REPORTED AN ISSUE WITH ONE BATCH OF API 20C STRIPS WHERE THE CUPS DRIED OUT TOO QUICKLY. IT WAS REPORTED THAT THE LID DIDN'T CLOSE TIGHTLY BECAUSE IT WAS DEFORMED, BUT EVEN WHEN ADDING TAPE IT DRIED OUT AND THE WATER PUT UNDER THE STRIP EVAPORATED COMPLETELY. THE CUSTOMER PERFORMED AN ANTIFUNGIOGRAM WITHOUT HAVING THE IDENTIFICATION BECAUSE NO OTHER METHODS WERE AVAILABLE. PER PHOTOS SENT BY THE CUSTOMER, THE WATER IN THE HONEY-WELLS AND THE SUSPENSION INSIDE THE STRIPS WELLS ARE DEHYDRATED. CONSEQUENTLY, THE PROFILE CANNOT BE READ. IT WAS HIGHLIGHTED BY BIOMÉRIEUX G

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218297 ↗
• MalfunctionApr 27, 2022Nonstandard Device; Nonstandard Device

  INTENDED USE: API® 20 C AUX IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE PRECISE IDENTIFICATION OF THE MOST FREQUENTLY ENCOUNTERED YEASTS. IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY ADAPTED DATABASE. INOCULATION AND READING OF THE STRIP ARE PERFORMED MANUALLY AND THE IDENTIFICATION IS OBTAINED USING AN IDENTIFICATION SOFTWARE. INCIDENT DESCRIPTION: A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX A STRIP ISSUE LEADING TO "NO RESULT" IN ASSOCIATION WITH THE PRODUCT API 20 C AUX 25 STRIPS+25MEDIA (REF 20210, BATCH NUMBER 1009159121, EXPIRY DATE 03-JUL-2023) WITH FOUR PATIENT'S STRAINS (OPHTHALMIC SAMPLES). THE CUSTOMER REPORTED AN ISSUE WITH ONE BATCH OF API 20C STRIPS WHERE THE CUPS DRIED OUT TOO QUICKLY. IT WAS REPORTED THAT THE LID DIDN'T CLOSE TIGHTLY BECAUSE IT WAS DEFORMED, BUT EVEN WHEN ADDING TAPE IT DRIED OUT AND THE WATER PUT UNDER THE STRIP EVAPORATED COMPLETELY. THE CUSTOMER PERFORMED AN ANTIFUNGIOGRAM WITHOUT HAVING THE IDENTIFICATION BECAUSE NO OTHER METHODS WERE AVAILABLE. PER PHOTOS SENT BY THE CUSTOMER, THE WATER IN THE HONEY-WELLS AND THE SUSPENSION INSIDE THE STRIPS WELLS ARE DEHYDRATED. CONSEQUENTLY, THE PROFILE CANNOT BE READ. IT WAS HIGHLIGHTED BY BIOMÉRIEUX G

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218294 ↗
• MalfunctionApr 27, 2022Nonstandard Device; Nonstandard Device

  INTENDED USE: API® 20 C AUX IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE PRECISE IDENTIFICATION OF THE MOST FREQUENTLY ENCOUNTERED YEASTS. IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY ADAPTED DATABASE. INOCULATION AND READING OF THE STRIP ARE PERFORMED MANUALLY AND THE IDENTIFICATION IS OBTAINED USING AN IDENTIFICATION SOFTWARE. INCIDENT DESCRIPTION: A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX A STRIP ISSUE LEADING TO "NO RESULT" IN ASSOCIATION WITH THE PRODUCT API 20 C AUX 25 STRIPS+25MEDIA (REF 20210, BATCH NUMBER 1009159121, EXPIRY DATE 03-JUL-2023) WITH FOUR PATIENT'S STRAINS (OPHTHALMIC SAMPLES). THE CUSTOMER REPORTED AN ISSUE WITH ONE BATCH OF API 20C STRIPS WHERE THE CUPS DRIED OUT TOO QUICKLY. IT WAS REPORTED THAT THE LID DIDN'T CLOSE TIGHTLY BECAUSE IT WAS DEFORMED, BUT EVEN WHEN ADDING TAPE IT DRIED OUT AND THE WATER PUT UNDER THE STRIP EVAPORATED COMPLETELY. THE CUSTOMER PERFORMED AN ANTIFUNGIOGRAM WITHOUT HAVING THE IDENTIFICATION BECAUSE NO OTHER METHODS WERE AVAILABLE. PER PHOTOS SENT BY THE CUSTOMER, THE WATER IN THE HONEY-WELLS AND THE SUSPENSION INSIDE THE STRIPS WELLS ARE DEHYDRATED. CONSEQUENTLY, THE PROFILE CANNOT BE READ. IT WAS HIGHLIGHTED BY BIOMÉRIEUX G

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218275 ↗
• MalfunctionSep 20, 2021False Negative Result; False Negative Result

  INTENDED USE: API® 20 C AUX IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE PRECISE IDENTIFICATION OF THE MOST FREQUENTLY ENCOUNTERED YEASTS. IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY ADAPTED DATABASE. INOCULATION AND READING OF THE STRIP ARE PERFORMED MANUALLY AND THE IDENTIFICATION IS OBTAINED USING AN IDENTIFICATION SOFTWARE. DESCRIPTION OF THE ISSUE: A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF QUALITY CONTROL TEST FAILURE WITH CYPTOCOCCUS LAURENTII ATCC® STRAIN WHEN USING THE PRODUCT API® 20 C AUX (REFERENCE 20210 - LOT 1008311320 - EXPIRATION DATE : 23/03/2022). THE API® 20 C AUX DID NOT PRODUCE A TURBID (POSITIVE) RESULT FOR THE MDG WELL AS EXPECTED. PER THE INSTRUCTIONS FOR USE (IFU), CRYPTOCOCCUS LAURENTII ATCC® 18803¿ PRESENT POSITIVE REACTIONS FOR ALL WELLS EXCEPT FOR GLY AND TRE. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497663 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). 12 WERE YEAST ISOLATES: 6 TRICHOSPORON ASAHII, 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703922 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: - 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). -12 WERE YEAST ISOLATES 6 TRICHOSPORON ASAHII 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703918 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: - 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). -12 WERE YEAST ISOLATES 6 TRICHOSPORON ASAHII 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703915 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: - 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). -12 WERE YEAST ISOLATES 6 TRICHOSPORON ASAHII 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703912 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: - 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). -12 WERE YEAST ISOLATES 6 TRICHOSPORON ASAHII 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703909 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUSITANIAE (N = 3, 3%). 12 WERE YEAST ISOLATES: 6 TRICHOSPORON ASAHII; 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703904 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: - 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). -12 WERE YEAST ISOLATES 6 TRICHOSPORON ASAHII 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703903 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUSITANIAE (N = 3, 3%). 12 WERE YEAST ISOLATES: 6 TRICHOSPORON ASAHII; 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703901 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: - 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). -12 WERE YEAST ISOLATES 6 TRICHOSPORON ASAHII 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703896 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: - 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). -12 WERE YEAST ISOLATES 6 TRICHOSPORON ASAHII 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703894 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: - 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). -12 WERE YEAST ISOLATES 6 TRICHOSPORON ASAHII 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703892 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: - 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). -12 WERE YEAST ISOLATES 6 TRICHOSPORON ASAHII 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703890 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: - 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). -12 WERE YEAST ISOLATES 6 TRICHOSPORON ASAHII 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703888 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). 12 WERE YEAST ISOLATES: 6 TRICHOSPORON ASAHII, 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703883 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: - 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). -12 WERE YEAST ISOLATES 6 TRICHOSPORON ASAHII 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703882 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: - 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). -12 WERE YEAST ISOLATES 6 TRICHOSPORON ASAHII 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703881 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). 12 WERE YEAST ISOLATES: 6 TRICHOSPORON ASAHII, 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703878 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: 88 ISOLATES WERE FOUND TO BE CANDIDA SP. FAMATA (N = 33, 33%), TROPICALIS (N = 15, 15%), ALBICANS (N = 12, 12%), PARAPSILLOSIS (N = 10, 10%), GLABRATA (N = 7, 7%), KRUSEI (N = 5, 5%) GUILLIERMONDII (N = 3, 3%) LUISITANIAE (N = 3, 3%). 12 WERE YEAST ISOLATES: 6 TRICHOSPORON ASAHII, 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE FOLLOWING IDENTIFICATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703877 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: - 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). -12 WERE YEAST ISOLATES 6 TRICHOSPORON ASAHII 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703871 ↗
• MalfunctionApr 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "MALDI-TOF MS OVERCOMES MISIDENTIFICATION OF THE UNCOMMON HUMAN PATHOGEN CANDIDA FAMATA BY ROUTINE PHENOTYPIC IDENTIFICATION METHODS" BY GHAITH, D. ET AL. IN THE PUBLICATION, THERE WERE 100 CLINICALLY ISOLATED YEAST STRAINS FROM 100 DIFFERENT PATIENTS THAT WERE IDENTIFIED USING API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210, LOT NUMBER UNKNOWN). THE ISOLATES WERE COLLECTED BETWEEN DECEMBER 2018 AND DECEMBER 2019. THIS ARTICLE IS A RETROSPECTIVE ANALYSIS OF THE YEAST ISOLATES COLLECTED FROM PATIENTS. THE FOLLOWING IS THE IDENTIFICATION OF THE 100 ISOLATES USING THE API 20 C AUX 25 STRIPS+25MEDIA: - 88 ISOLATES WERE FOUND TO BE CANDIDA SP. C. FAMATA (N = 33, 33%), C. TROPICALIS (N = 15, 15%), C. ALBICANS (N = 12, 12%), C. PARAPSILLOSIS (N = 10, 10%), C. GLABRATA (N = 7, 7%), C. KRUSEI (N = 5, 5%) C. GUILLIERMONDII (N = 3, 3%) C. LUISITANIAE (N = 3, 3%). -12 WERE YEAST ISOLATES 6 TRICHOSPORON ASAHII 6 TRICHOSPORON MUCOIDES. THE THIRTY-THREE (33) ISOLATES THAT WERE IDENTIFIED AS CANDIDA FAMATA BY API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210) WERE RE-IDENTIFIED USING THE VITEK MS AND OBTAINED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703847 ↗