VITEK® 2 YSTRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 03573026529697), received between Mar 23, 2017 and Aug 21, 2018 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (19 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-0789-2023 · Root cause: Storage · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A POSTER PRESENTED AT THE AMMI-CACMID MEETING (CANADIAN MICROBIOLOGY CONVENTION) CONTAINED INFORMATION ON THE MISIDENTIFICATIONS OF CANDIDA AURIS ISOLATES IN ASSOCIATION WITH THE VITEK® 2 YST TEST KIT. BIOMÉRIEUX CONTACTED THE AUTHOR FOR MORE INFORMATION. IT WAS REPORTED THAT C. AURIS WAS MISIDENTIFIED AS C. DUOBUSHAEMULONII AND C.LUSITANIAE/C. DUOBUSHAEMULONII. THE AUTHOR WHO PERFORMED THE TESTING, SENT THEIR SURVEY RESULTS TO THE (B)(6), WHICH THEY HAD OBTAINED USING VITEK 2 VERSION 7.01. THE AUTHOR STATED NO C.AURIS ISOLATES WERE IDENTIFIED BY VITEK 2 V7.01 IN THEIR LAB. AT THE SAME TIME, THEIR LAB WAS UPGRADED TO VITEK 2 V8.01. TESTING WAS THEN REPEATED WITH THE NEW VERSION 8.01. THERE WAS A MISCOMMUNICATION WITH THE (B)(6) ABOUT TESTING WITH THE TWO VERSIONS UPON THE POSTER ABSTRACT REVIEW. (B)(6). THERE WAS NO PATIENT INVOLVEMENT AS TESTING WAS PERFORMED ON SURVEY SAMPLES. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7802216 ↗
• MalfunctionAug 13, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF A CANDIDA INCONSPICUA SPECIES EXTERNAL QUALITY CONTROL STRAIN (EEQ ABP MYCOLOGIE 17-4C) IN ASSOCIATION WITH THE VITEK®2 YST TEST KIT. THE CUSTOMER TESTED THE EEQ STRAIN FROM CHROMID® CANDIDA MEDIA (18-24H OF INCUBATION) ON THE YST CARD AND THE IDENTIFICATION WAS C. KRUSEI/C. INCONSPICUA (50/50%). THE TEST WAS REPEATED FROM ANOTHER UNKNOWN MEDIA AND THE RESULT WAS C. KRUSEI (98%). THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO AN EXTERNAL QC STRAIN. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7778120 ↗
• MalfunctionJun 12, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF CAP SURVEY STRAIN CANDIDA TROPICALIS IN ASSOCIATION WITH THE VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT. THE VITEK 2 YST ID CARD IDENTIFIED THE STRAIN TO CANDIDA PARAPSILOSIS. FOLLOWING RECEIPT OF THE CAP ANSWER, THE CUSTOMER RETESTED THE ORIGINAL CAP STRAIN VIA YST ID CARD; OBTAINED RESULTS OF CANDIDA LUSITANIAE AND CANDIDA HAEMULONII. TESTING OF A SECOND SPECIMEN FROM CAP PROVIDED AN ORGANISM IDENTIFICATION TO THE EXPECTED RESULT OF CANDIDA TROPICALIS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PERSON'S STATE OF HEALTH, AS THERE IS NO PATIENT ASSOCIATED WITH THE CAP SURVEY STRAIN, BIOMÉRIEUX REQUESTED STRAIN SUBMITTAL FROM THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7591900 ↗
• MalfunctionJun 12, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF CAP SURVEY STRAIN CANDIDA GUILLIERMONDI IN ASSOCIATION WITH THE VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT. THE VITEK 2 YST ID CARD IDENTIFIED THE STRAIN TO CANDIDA FAMATA. REPEAT TEST OBTAINED THE SAME RESULT. THE CUSTOMER SUBMITTED THE IDENTIFICATION OF CANDIDA FAMATA TO CAP. CAP INDICATED THE RESULT TO BE INCORRECT; CANDIDA GUILLIERMONDI WAS THE EXPECTED RESULT. THE CUSTOMER STATED THEY PLATE THE DIRECT SPECIMEN, SUB-CULTURE IT ONCE, THEN TEST ON THE VITEK 2 SYSTEM ACCORDING TO CAP INSTRUCTIONS. FOLLOWING RECEIPT OF THE CAP ANSWER, THE CUSTOMER PERFORMED TESTING ON THE CAP STRAIN VIA VITEK MS, AND OBTAINED THE EXPECTED RESULT OF CANDIDA GUILLIERMONDI. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PERSON'S STATE OF HEALTH, AS THERE IS NO PATIENT ASSOCIATED WITH THE CAP SURVEY STRAIN, BIOMÉRIEUX REQUESTED STRAIN SUBMITTAL FROM THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7590866 ↗
• MalfunctionJun 1, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A YEAST MISIDENTIFICATION FOR A CAP SURVEY SAMPLE (SURVEY (B)(4) 2018) IN ASSOCIATION WITH THE VITEK® 2 YST TEST KIT (LOT # 2430224403). THE EXPECTED RESULT FOR THIS SPECIFIC CAP SURVEY SAMPLE, SPECIMEN (B)(4), INCLUDED CANDIDA GUILLIERMONDII, CANDIDA FAMATA/GUILLIERMONDII OR CANDIDA SPECIES, NOT ALBICANS. WITH INITIAL TESTING ON (B)(6) 2018, VITEK 2 OBTAINED A LOW DISCRIMINATION RESULT BETWEEN CANDIDA FAMATA / CANDIDA GUILLIERMONDII AS EXPECTED. THE CUSTOMER REPEATED TESTING ON (B)(6) 2018 AND OBTAINED A RESULT OF CANDIDA FAMATA AS A SINGLE-CHOICE ORGANISM. 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 Patient Involvement

  MAUDE report 7562241 ↗
• MalfunctionJun 1, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A YEAST MISIDENTIFICATION FOR A CAP SURVEY SAMPLE (SURVEY F1-A 2018) IN ASSOCIATION WITH THE VITEK® 2 YST TEST KIT (LOT # 2430398203). VITEK 2 OBTAINED A RESULT OF CANDIDA FAMATA AS A SINGLE-CHOICE ORGANISM. THE EXPECTED RESULT FOR THIS SPECIFIC CAP SURVEY SAMPLE, SPECIMEN F1-02, INCLUDED CANDIDA GUILLIERMONDII, CANDIDA FAMATA/GUILLIERMONDII OR CANDIDA SPECIES, NOT ALBICANS. 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 Patient Involvement

  MAUDE report 7562017 ↗
• MalfunctionJun 1, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A YEAST MISIDENTIFICATION FOR A CAP SURVEY SAMPLE (SURVEY F1-A 2018) IN ASSOCIATION WITH THE VITEK® 2 YST TEST KIT (LOT # 2430224403). VITEK 2 OBTAINED A RESULT OF CANDIDA PARAPSILOSIS AS A SINGLE-CHOICE ORGANISM ON INITIAL TESTING. THE EXPECTED RESULT FOR THIS SPECIFIC CAP SURVEY SAMPLE, SPECIMEN F1-01, INCLUDED CANDIDA TROPICALIS OR CANDIDA SPECIES, NOT ALBICANS. AFTER RECEIVING THE SURVEY RESULTS, THE CUSTOMER REPEATED TESTING AND OBTAINED AN IDENTIFICATION OF CANDIDA TROPICALIS AS EXPECTED. 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 Patient Involvement

  MAUDE report 7561021 ↗
• MalfunctionJun 1, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A YEAST MISIDENTIFICATION FOR A CAP SURVEY SAMPLE (SURVEY F1-A 2018) IN ASSOCIATION WITH THE VITEK® 2 YST TEST KIT (LOT # 2430224403). VITEK 2 OBTAINED A RESULT OF CANDIDA FAMATA AS A SINGLE-CHOICE ORGANISM ON INITIAL TESTING. THE EXPECTED RESULT FOR THIS SPECIFIC CAP SURVEY SAMPLE, SPECIMEN F1-02, INCLUDED CANDIDA GUILLIERMONDII, CANDIDA FAMATA/GUILLIERMONDII OR CANDIDA SPECIES, NOT ALBICANS. UPON SECOND TESTING, THE CUSTOMER OBTAINED A LOW DISCRIMINATION RESULT BETWEEN CANDIDA FAMATA / CANDIDA GUILLIERMONDII AS EXPECTED. 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 Patient Involvement

  MAUDE report 7561018 ↗
• MalfunctionMay 31, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN THE UNITED STATES REPORTED A MISIDENTIFICATION OF A CANDIDA GUILLIERMONDII CAP SURVEY SAMPLE (F1-02), AS CANDIDA FAMATA IN ASSOCIATION WITH THE VITEK® 2 YST TEST KIT. THE CUSTOMER REPORTED CANDIDA FAMATA AS THEIR IDENTIFICATION. REPEAT TESTING GAVE A RESULT OF LOW DISCRIMINATION BETWEEN C. GUILLERMONDII AND C. FAMATA. THE CUSTOMER SUBMITTED THE LAB AND THE CAP SURVEY REPORTS FOR EVALUATION. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7558261 ↗
• MalfunctionMay 24, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER FROM THE UNITED STATED REPORTED A MISIDENTIFICATION OF A CANDIDA TROPICALIS CAP SURVEY SAMPLE (F-01 FA 2018) AS CANDIDA PARAPSILOSIS IN ASSOCIATION WITH THE VITEK® 2 YST TEST KIT. THE TESTED WAS REPEATED THREE TIMES AND THE RESULT WAS CANDIDA PARAPSILOSIS TWICE AT 93% AND ONCE AT 95%. BIOMÉRIEUX REQUESTED THE SURVEY AND TEST REPORTS FROM THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7542396 ↗
• MalfunctionMay 23, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER FROM THE UNITED STATES REPORTED A YEAST MISIDENTIFICATION FOR A CAP SURVEY SAMPLE ((B)(6)) IN ASSOCIATION WITH THE VITEK® 2 YST TEST KIT (LOT #2430541203). THE CUSTOMER STATED BOTH SAMPLES FROM THE TWO LOOPS RECEIVED, WERE INITIALLY IDENTIFIED AS CANDIDA FAMATA WITH THE VITEK YST CARD. AFTER RECEIVING THE EXPECTED CAP RESULT OF C. GUILLIERMONDII, THE CUSTOMER RETESTED FROM BOTH LOOPS WITH A DIFFERENT YST CARD (LOT #2430611103) AND RECEIVED A LOW DISCRIMINATION C. GUILLMONDO/FAMATA. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7536764 ↗
• MalfunctionMay 8, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  DURING LITERATURE REVIEW PERFORMED BY BIOMÉRIEUX, MISIDENTIFICATION RESULTS WERE NOTED IN A STUDY JOINTLY COLLABORATED BY (B)(6). THE RESULTS WERE SUMMARIZED IN THE ARTICLE, "CLINICALLY RELEVANT YEAST SPECIES IDENTIFIED BY SEQUENCING THE INTERNAL TRANSCRIBED SPACER REGION OF R-RNA GENE AND VITEK 2 COMPACT (YST CARD) COMMERCIAL IDENTIFICATION SYSTEM: EXPERIENCE IN A TERTIARY CARE HOSPITAL IN ASSAM, NORTHEAST INDIA," AUTHORED BY REEMA NATH, REETA BORA, BISWAJYOTI BORKAKOTY, LAHARI SAIKIA, AND PRATAP PARIDA. ACCORDING TO THE ARTICLE, VITEK® 2 YST ID TEST KIT (REF 21343), MISIDENTIFIED UNCLAIMED SPECIES AS FOLLOWS: CUTANEOTRICHOSPORON DEBEURMANNIANUM WAS MISIDENTIFIED AS CRYPTOCOCCUS LAURENTII, CANDIDA METAPSILOSIS WAS MISIDENTIFIED AS CANDIDA PARAPSILOSIS, CANDIDA MESORUGOSA WAS MISIDENTIFIED AS CANDIDA RUGOSA, CANDIDA AKABANENSIS WAS MISIDENTIFIED AS CANDIDA RUGOSA. THERE IS NO INDICATION FROM THE ARTICLE THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7496443 ↗
• MalfunctionMay 8, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  DURING LITERATURE REVIEW PERFORMED BY BIOMÉRIEUX, MISIDENTIFICATION RESULTS WERE NOTED IN A STUDY JOINTLY COLLABORATED BY ASSAM MEDICAL COLLEGE AND HOSPITAL AND REGIONAL MEDICAL RESEARCH CENTER, DIBRUGARH, ASSAM, INDIA. THE RESULTS WERE SUMMARIZED IN THE ARTICLE, "CLINICALLY RELEVANT YEAST SPECIES IDENTIFIED BY SEQUENCING THE INTERNAL TRANSCRIBED SPACER REGION OF R-RNA GENE AND VITEK 2 COMPACT (YST CARD) COMMERCIAL IDENTIFICATION SYSTEM: EXPERIENCE IN A TERTIARY CARE HOSPITAL IN ASSAM, NORTHEAST INDIA," AUTHORED BY REEMA NATH, REETA BORA, BISWAJYOTI BORKAKOTY, LAHARI SAIKIA, AND PRATAP PARIDA. ACCORDING TO THE ARTICLE, VITEK® 2 YST ID TEST KIT (REF 21343), MISIDENTIFIED THE FOLLOWING SPECIES AS CANDIDA FAMATA: MEYEROZYMA GUILLIERMONDII, CANDIDA ALBICANS, TRICHOSPORON ASAHII, CANDIDA PARAPSILOSIS, CANDIDA TROPICALIS AND WICKERHAMOMYCES ANOMALUS. THERE IS NO INDICATION FROM THE ARTICLE THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7495942 ↗
• MalfunctionMay 8, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  DURING LITERATURE REVIEW PERFORMED BY BIOMÉRIEUX, A MISIDENTIFICATION RESULT WAS NOTED IN THE ARTICLE "CANDIDA AURIS: A SYSTEMIC REVIEW AND META-ANALYSIS OF CURRENT UPDATES ON AN EMERGING MULTIDRUG-RESISTANT PATHOGEN," AUTHORED BY JOHN OSEI SEKYERE. ACCORDING TO THE ARTICLE, VITEK® 2 YST ID TEST KIT (REF 21343), MISIDENTIFIED CANDIDA AURIS AS CANDIDA HAEMULONII AND CANDIDA DUOBUSHAEMULONII. IT SHOULD BE NOTED THAT C. AURIS WAS NOT A CLAIMED SPECIES UNTIL VITEK 2 VERSION 8.01 FOR YST CARDS. THE ARTICLE ALSO CITES ARTICLES REGARDING VITEK 2 ANTIFUNGAL TESTING DESPITE THE FACT THAT C. AURIS IS NOT CLAIMED ON VITEK 2 ANTIFUNGAL CARDS. THERE IS NO INDICATION FROM THE ARTICLE THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7494115 ↗
• MalfunctionApr 27, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  AN INDUSTRY CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS WHEN TESTING CANDIDA ALBICANS QUALITY CONTROL STRAIN, ATCC (B)(4), WITH VITEK® 2 YST TEST KIT (REF. 21343), LOT. # 2430555203. THE CUSTOMER STATED THAT VITEK 2 OBTAINED AN IDENTIFICATION AS STEPHANOASCUS CIFERRII SPECIES. THE CUSTOMER STATED THAT HE USED THE STRAIN AFTER THREE TO FIVE DAYS OF INCUBATION AT 22.5°C. THE STRAIN WAS GROWN ON SDA MEDIA BEFORE TESTING ON VITEK 2, AND THE CUSTOMER USED A MCFARLAND AT 1.8-2.2. BASED ON DATA PROVIDED BY THE CUSTOMER, THE INSTRUCTIONS FOR USE WERE NOT FOLLOWED DURING THIS FIRST TESTING AS THE STRAIN NEEDS TO BE NO OLDER THAN THREE DAYS AND INCUBATION NEEDS TO BE DONE AT 30° TO 37°C, AEROBIC NON -CO2 CONDITIONS. THEREFORE, THE CUSTOMER WAS REQUESTED TO PERFORM A RETEST FOLLOWING THE INSTRUCTIONS FOR USE. UPON RETESTING, THE CUSTOMER OBTAINED THE SAME MISIDENTIFICATION RESULT OF ST. CIFERRII SPECIES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT QUALITY RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL SAMPLE. TO BE NOTED, AS SPECIFIED IN THE INSTRUCTIONS

  Patient problems: No Patient Involvement

  MAUDE report 7470256 ↗
• MalfunctionApr 26, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF A CANDIDA AURIS STRAIN FROM A PATIENT'S EAR SWAB AS CANDIDA DUOBUSHEMULONII IN ASSOCIATION WITH THE VITEK® 2 YST TEST KIT (LOT 2430518203). THE CUSTOMER REPORTED THAT THE PATIENT ISOLATE WAS INITIALLY IDENTIFIED CORRECTLY AS C. AURIS (90%) WITH THE YST CARD. HOWEVER, REPEAT TESTING WITH THE YST CARD IDENTIFIED CANDIDA DUOBUSHEMULONII. THE BRUKER ID OBTAINED IDENTIFICATION OF C. AURIS BUT WITH A BAD SCORE IN RESEARCH USE ONLY MODE. THE CONTROL STRAIN (CBS 10913) ALSO MISIDENTIFIED AS C. DUOBUSHEMULONII. THE CUSTOMER STATED THAT STRAINS WERE TESTED ON TWO DIFFERENT INSTRUMENTS, WITH TWO DIFFERENT LOTS. THE MEDIA USED FOR THE FIRST TESTING WAS PVX (CHOCOLATE AGAR + POLYVITEX) AND WAS USED AFTER 24H CO2 35°C. THE RETESTING WAS DONE FROM CHROMID® CANDIDA AFTER 48H 35°C AND 72H 35°C. THE CUSTOMER REPORTED THAT PATIENT RESULTS AND TREATMENT WERE NOT IMPACTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7466570 ↗
• MalfunctionApr 26, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF A CANDIDA AURIS STRAIN FROM A PATIENT'S EAR SWAB, AS CANDIDA DUOBUSHEMULONII, IN ASSOCIATION WITH THE VITEK® 2 YST TEST KIT (LOT 2430316403). THE CUSTOMER REPORTED THAT THE PATIENT ISOLATE WAS INITIALLY IDENTIFIED CORRECTLY AS C. AURIS (90%) WITH THE YST CARD. HOWEVER, REPEAT TESTING WITH THE YST CARD IDENTIFIED CANDIDA DUOBUSHEMULONII. THE BRUKER ID OBTAINED IDENTIFICATION OF C. AURIS BUT WITH A BAD SCORE IN RESEARCH USE ONLY MODE. THE CONTROL STRAIN ((B)(4)) ALSO MISIDENTIFIED AS C. DUOBUSHEMULONII. THE CUSTOMER STATED THAT THE STRAINS WERE TESTED ON TWO DIFFERENT INSTRUMENTS, WITH TWO DIFFERENT LOTS. THE MEDIA USED FOR THE FIRST TESTING WAS PVX (CHOCOLATE AGAR + POLYVITEX) AND WAS USED AFTER 24H CO2 35°C. THE RETESTING WAS DONE FROM CHROMID® CANDIDA AFTER 48H 35°C AND 72H 35°C. THE CUSTOMER REPORTED THAT PATIENT RESULTS AND TREATMENT WERE NOT IMPACTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7466564 ↗
• MalfunctionApr 2, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF CANDIDA AURIS AS CANDIDA HAEMULONII IN ASSOCIATION WITH THE VITEK® 2 YST ID TEST KIT. THE CUSTOMER SENT THE ORGANISM STRAINS TO A REFERENCE LABORATORY FOR CONFIRMATORY TESTING VIA VITEK 2; THE REFERENCE LABORATORY CONFIRMED THE IDENTIFICATION TO CANDIDA HAEMULONII. THE CUSTOMER ALSO SENT THE ORGANISM STRAINS TO A REFERENCE LABORATORY FOR CONFIRMATORY TESTING VIA (B)(4); THE RESULTS WERE RETURNED AS CANDIDA AURIS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL HAS BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7388935 ↗
• MalfunctionApr 2, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF CANDIDA AURIS AS CANDIDA HAEMULONII IN ASSOCIATION WITH THE VITEK® 2 YST ID TEST KIT. THE CUSTOMER SENT THE ORGANISM STRAINS TO A REFERENCE LABORATORY FOR CONFIRMATORY TESTING VIA VITEK 2; THE REFERENCE LABORATORY CONFIRMED THE IDENTIFICATION TO CANDIDA HAEMULONII. THE CUSTOMER ALSO SENT THE ORGANISM STRAINS TO A REFERENCE LABORATORY FOR CONFIRMATORY TESTING VIA BRUKER MALDI TOF; THE RESULTS WERE RETURNED AS CANDIDA AURIS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL HAS BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7388933 ↗
• MalfunctionMar 27, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF CRYPTOCOCCUS NEOFORMANS AS RHODOTORULA MINUTA IN ASSOCIATION WITH THE VITEK® 2 YEAST (YST) TEST KIT (LOT 2430420103). REPEAT TESTING WAS NOT PERFORMED AND THE CRYPTOCOCCUS NEOFORMANS IDENTIFICATION WAS OBTAINED VIA PCR. THE CUSTOMER INDICATED THERE WAS GREATER THAN 24 HOURS FOR REPORTING RESULTS DUE TO THE TESTING PERFORMED AT A REFERENCE LAB. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7373988 ↗
• MalfunctionMar 15, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF A CANDIDA NORVEGENSIS QUALITY CONTROL SAMPLE (EEQ BIOLOGY PROSPECTIVE), AS CANDIDA KRUSEI IN ASSOCIATION WITH THE VITEK® 2 YST TEST KIT (LOT 2430385203). THE MEDIA USED WAS CHROMID® CANDIDA. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7341720 ↗
• MalfunctionMar 12, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK®2 YST TEST KIT (REFERENCE 21343). THE CUSTOMER REPORTED MISIDENTIFICATION OF CANDIDA AURIS ON VITEK®2 V7.01 SYSTEM. CUSTOMER PERFORMED EXTERNAL RING TRIAL FOR CANDIDA. ONE OF THE STRAINS SHOULD BE CANDIDA AURIS, WHICH IS NOT INCLUDED IN THE CURRENT CUSTOMER KNOWLEDGE BASE. THE CUSTOMER REPORTED GETTING A 94% RESULT OF CANDIDA HAEMULONII ON VITEK® 2 AND 99.9% ON VITEK® MS. THERE IS NO PATIENT ASSOCIATED WITH THIS TEST SAMPLE BECAUSE IT WAS FOR AN EXTERNAL RING TRIAL. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7330866 ↗
• MalfunctionMar 8, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF CRYPTOCOCCUS NEOFORMANS AS RHODOTORULA MINUTA IN ASSOCIATION WITH THE VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT. NO REPEAT YST ID TESTING WAS PERFORMED. THE CRYPTOCOCCUS NEOFORMANS RESULT WAS OBTAINED VIA PCR. THE CUSTOMER INDICATES A DELAY OF >24 HOURS DUE TO ID/AST TESTING PERFORMED AT A REFERENCE LAB. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX REQUESTED THE PATIENT ISOLATE BE SUBMITTED FOR INVESTIGATION. BIOMÉRIEUX INVESTIGATION WILL BE CONDUCTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7324135 ↗
• MalfunctionMar 6, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK®2 YST TEST KIT (REFERENCE (B)(4)). THE CUSTOMER REPORTED THAT THE RHODOTORULA SPP IS NOT RELATED PHYLOGENETICALLY WITH THE CRYPTOCOCCUS, AND INSTEAD OF A MISTAKEN IDENTIFICATION AS OTHER CRYPTOCOCCUS SP, VITEK® 2 GAVE A RESULT OF RHODOTORULA AS TESTED IDENTIFICATION, AND SOMEHOW GAVE ALTERNATIVE POSSIBILITY OF CRYPTOCOCCUS ALBIDUS IN THE ANALYSIS MESSAGE. THE PERCENTAGE IDENTIFICATION OF (B)(6)% IS LOW, AND (B)(6) INK DOES NOT DIFFERENTIATE THESE ORGANISM AS BOTH SHOWN ENCAPSULATED BUDDING YEAST CELL. THE SAMPLE USED WAS FOR QUALITY ASSURANCE TESTING. THERE WAS NO EFFECT ON PATIENT TREATMENT OR CONDITION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7317244 ↗
• MalfunctionFeb 21, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF CANDIDA GLABRATA AS CANDIDA ZELLANOIDES IN ASSOCIATION WITH THE VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT. THE CANDIDA GLABRATA RESULT WAS OBTAINED FROM BIOFIRE AND MORPHOLOGY PLATE. THE CUSTOMER INDICATED THEY NO LONGER HAS THE PATIENT STRAINS. IN ADDITION, THE CUSTOMER WAS NOT WILLING TO PROVIDE ADDITIONAL DETAILS REGARDING PATIENT SYMPTOMS, TREATMENTS, OUTCOMES, ETC. THERE WAS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7287032 ↗