CHROMID® Candida AgarRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 03573026599812), received between Apr 25, 2017 and Nov 3, 2025 — classified as 28 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (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-0801-2023 · Root cause: Storage · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025False Positive Result; False Positive Result

  INTENDED USE: CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION OF YEASTS AND THE DIRECT IDENTIFICATION OF CANDIDA ALBICANS. THIS MEDIUM IS A MEDIUM FOR: THE SELECTIVE ISOLATION OF YEASTS, THE IDENTIFICATION OF THE SPECIES C. ALBICANS, THE PRESUMPTIVE DIFFERENTIATION OF A GROUP OF SPECIES COMPRISING C. TROPICALIS, C. LUSITANIAE AND C. KEFYR. ISSUE DESCRIPTION: A PUBLICATION IN FRANCE DOCUMENTS UNEXPECTED COLOR WITH CANDIDA CATENULATE STRAIN IN ASSOCIATION WITH CHROMID CANDIDA 20 PLATES (REF. 43631, LOT: UNKNOWN). BIOMERIEUX R&D AND MEDICAL AFFAIRS HAVE REVIEWED THE PUBLICATION PMS 383124886: ¿A ONE HEALTH PERSPECTIVE ON DIUTINA CATENULATA: PHENOTYPIC TRAITS, STRESS SENSITIVITY, AND VIRULENCE ACROSS DIVERSE ISOLATES ALBURQUERQUE ET AL., METHOD AND PROTOCOLS, 2025¿. 1) NATURE OF THE EVENT AND IMPACT. THIS STUDY AIMED TO PHENOTYPICALLY CHARACTERIZE DIUTINA CATENULATA, FORMERLY CANDIDA CATENULATE, ISOLATES FROM DIFFERENT ORIGINS (HUMAN, VETERINARY, AND ENVIRONMENTAL). ALL STRAINS WERE PREVIOUSLY IDENTIFIED USING THE VITEK® MS (DATABASE V3.2.0) AND FURTHER CONFIRMED BY ITS RDNA SEQUENCING. ISOLATES WERE CULTURED ONTO CHROMID® CANDIDA AGAR. C. ALBICANS SC5314, C. PARAPSILOSIS ATCC 22019, C.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451260 ↗
• MalfunctionJul 10, 2023False Negative Result; False Negative Result

  PRODUCT DESCRIPTION: CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION OF YEASTS AND THE DIRECT IDENTIFICATION OF CANDIDA ALBICANS. THIS MEDIUM IS A MEDIUM FOR: THE SELECTIVE ISOLATION OF YEASTS, THE IDENTIFICATION OF THE SPECIES C. ALBICANS, THE PRESUMPTIVE DIFFERENTIATION OF A GROUP OF SPECIES COMPRISING C. TROPICALIS, C. LUSITANIAE AND C. KEFYR. COMPLAINT DESCRIPTION: A CUSTOMER IN SPAIN COMPLAINED AFTER OBSERVING ABSENCE OF GROWTH WHEN USING CHROMID CANDIDA 20 PLATES (REF (B)(4), LOT 1010039600). THE CUSTOMER SAID THAT THEY HAD INOCULTED VAGINAL SAMPLES ONTO CHOCOLATE AGAR PLATES AND THAT AFTER INCUBATION THEY HAD OBSEVED A MICROBIAL GROWTH. THE CUSTOMER STATES THAT THE SAME SAMPLES WERE INOCULATED ONTO CHROMID CANDIDA PLATES AND THAT AFTER INCUBATION NO YEAST GROWTH WAS OBTAINED. NO FURHTER DETAILS WERE PROVIDED. AT THE TIME OF THE GLOBAL ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17285883 ↗
• MalfunctionMar 10, 2022False Negative Result; False Negative Result

  INTENDED USE: CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION OF YEASTS AND THE DIRECT IDENTIFICATION OF CANDIDA ALBICANS. THIS MEDIUM IS A MEDIUM FOR: THE SELECTIVE ISOLATION OF YEASTS, THE IDENTIFICATION OF THE SPECIES C. ALBICANS, THE PRESUMPTIVE DIFFERENTIATION OF A GROUP OF SPECIES COMPRISING C. TROPICALIS, C. LUSITANIAE AND C. KEFYR. DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF OBSERVING NO GROWTH FOR CANDIDA ALBICANS ON CHROMID CANDIDA 20 PLATES (REF 43631, LOT 1009083210). THE CUSTOMER REPORTED THAT CANDIDA ALBICANS GROWS VERY LITTLE OR NOT AT ALL ON CHROMID CANDIDA 20 PLATES (REF 43631, LOT 1009083210) WHILE THE ORGANISMS GROW WELL ON PVX OR ANC AGARS. THE CUSTOMER ALSO PERFORMED TESTING OF A CANDIDA ALBICANS ATCC STRAIN IN PARALLEL WITH TWO DIFFERENT LOTS OF CHROMID CANDIDA (LOT 1009083210 AND LOT 1009159280). THE RESULTS SHOWED GROWTH ON LOT 1009159280 WHILE THERE WAS NO GROWTH ON LOT 1009083210. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13725562 ↗
• MalfunctionJan 25, 2022False Negative Result; False Negative Result

  INTENDED USE: CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION OF YEASTS AND THE DIRECT IDENTIFICATION OF CANDIDA ALBICANS. THIS MEDIUM IS A MEDIUM FOR: THE SELECTIVE ISOLATION OF YEASTS, THE IDENTIFICATION OF THE SPECIES C. ALBICANS, THE PRESUMPTIVE DIFFERENTIATION OF A GROUP OF SPECIES COMPRISING C. TROPICALIS, C. LUSITANIAE AND C. KEFYR. ISSUE DESCRIPTION: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF CANDIDA ALBICANS NO GROWTH IN ASSOCIATION WITH CHROMID CANDIDA 20 PLATES (REF. 43631, LOT 1009069930, EXPIRATION DATE 01-MAR-2022). THE TYPES OF SAMPLES TESTED WERE MAINLY SPUTUM, GENITAL SMEARS. IT WAS REPORTED THAT FOR SEVERAL MONTHS THE CLIENT HAS NOTICED THAT CANDIDA DO NOT GROW WELL ON CHROMID CANDIDA AGAR. THE CUSTOMER HAS PERFORMED A SABOURAUD AGAR IN PARALLEL AND THERE HE QUICKLY HAD LARGE COLONIES WHILE ON THE CAN 2 AT 48 HOURS THERE WERE VERY SMALL COLONIES. THE CUSTOMER HAS CONFIRMED THE IDENTIFICATION WITH MALDI-TOF. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13343334 ↗
• MalfunctionJan 25, 2022False Negative Result; False Negative Result

  INTENDED USE: CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION OF YEASTS AND THE DIRECT IDENTIFICATION OF CANDIDA ALBICANS. THIS MEDIUM IS A MEDIUM FOR: THE SELECTIVE ISOLATION OF YEASTS, THE IDENTIFICATION OF THE SPECIES C. ALBICANS, THE PRESUMPTIVE DIFFERENTIATION OF A GROUP OF SPECIES COMPRISING C. TROPICALIS, C. LUSITANIAE AND C. KEFYR. ISSUE DESCRIPTION: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF CANDIDA ALBICANS NO GROWTH IN ASSOCIATION WITH CHROMID CANDIDA 20 PLATES (REF. (B)(4), LOT 1009006390, EXPIRATION DATE 24-JAN-2022), THE TYPES OF SAMPLES TESTED WERE MAINLY SPUTUM, GENITAL SMEARS. THIS COMPLAINT IS RELATED TO THE COMPLAINT (B)(4) (SAME CUSTOMER, SAME ISSUE, SAME PRODUCT, BATCH NUMBER 1009069930). IT WAS REPORTED THAT FOR SEVERAL MONTHS, THE CLIENT HAS NOTICED THAT CANDIDA DO NOT GROW WELL ON CHROMID CANDIDA AGAR. THE CUSTOMER HAS PERFORMED A SABOURAUD AGAR IN PARALLEL AND THERE HE QUICKLY HAD LARGE COLONIES WHILE ON THE CAN 2 AT 48H THERE WERE VERY SMALL COLONIES THAT GREW. THE CUSTOMER HAS CONFIRMED THE IDENTIFICATION WITH MALDITOF. AT THE TIME OF THE GLOBAL ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13343026 ↗
• MalfunctionJan 20, 2022False Negative Result; False Negative Result

  INTENDED USE, CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION OF YEASTS AND THE DIRECT IDENTIFICATION OF CANDIDA ALBICANS. THIS MEDIUM IS A MEDIUM FOR THE SELECTIVE ISOLATION OF YEASTS, THE IDENTIFICATION OF THE SPECIES C. ALBICANS, THE PRESUMPTIVE DIFFERENTIATION OF A GROUP OF SPECIES COMPRISING C. TROPICALIS, C. LUSITANIAE AND C. KEFYR. DESCRIPTION, A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING NO GROWTH FOR CANDIDA ALBICANS STRAINS FROM FIVE (5) PATIENTS IN ASSOCIATION WITH CHROMID® CANDIDA 20 PLATES (REF 43631, LOT 1009006390). THE STRAINS WERE COLLECTED FROM VAGINAL SWAB SAMPLES. THE CUSTOMER REPORTED THAT THE STRAINS DID NOT GROW ON THE CHROMID CANDIDA MEDIA, BUT DID GROW ON PVX MEDIA. THE STRAINS WERE ALL IDENTIFIED AS CANDIDA ALBICANS WITH THE BRUKER MALDI. THE GROWTH ISSUE WAS OBSERVED AT THE END OF THE CUSTOMER'S USE OF THIS BATCH AND THERE ARE NO LONGER ANY PLATES FROM THIS BATCH REMAINING AT THE CUSTOMER'S SITE. THE STRAINS WERE MANUALLY SEEDED ON A DIFFERENT BATCH OF CHROMID CANDIDA AND ONE (1) OR TWO (2) COLONIES GREW. THE CUSTOMER CONFIRMED THAT RESULTS WERE NOT DELAYED AND NO INCORRECT RESULTS WERE REPORTED. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306970 ↗
• MalfunctionJan 20, 2022False Negative Result; False Negative Result

  INTENDED USE: CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION OF YEASTS AND THE DIRECT IDENTIFICATION OF CANDIDA ALBICANS. THIS MEDIUM IS A MEDIUM FOR: THE SELECTIVE ISOLATION OF YEASTS, THE IDENTIFICATION OF THE SPECIES C. ALBICANS, THE PRESUMPTIVE DIFFERENTIATION OF A GROUP OF SPECIES COMPRISING C. TROPICALIS, C. LUSITANIAE AND C. KEFYR. DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING NO GROWTH FOR CANDIDA ALBICANS STRAINS FROM FIVE (5) PATIENTS IN ASSOCIATION WITH CHROMID® CANDIDA 20 PLATES (REF (B)(4), LOT 1009006390). THE STRAINS WERE COLLECTED FROM VAGINAL SWAB SAMPLES. THE CUSTOMER REPORTED THAT THE STRAINS DID NOT GROW ON THE CHROMID CANDIDA MEDIA, BUT DID GROW ON PVX MEDIA. THE STRAINS WERE ALL IDENTIFIED AS CANDIDA ALBICANS WITH THE BRUKER MALDI. THE GROWTH ISSUE WAS OBSERVED AT THE END OF THE CUSTOMER'S USE OF THIS BATCH AND THERE ARE NO LONGER ANY PLATES FROM THIS BATCH REMAINING AT THE CUSTOMER'S SITE. THE STRAINS WERE MANUALLY SEEDED ON A DIFFERENT BATCH OF CHROMID CANDIDA AND ONE (1) OR TWO (2) COLONIES GREW. THE CUSTOMER CONFIRMED THAT RESULTS WERE NOT DELAYED AND NO INCORRECT RESULTS WERE REPORTED. THERE IS NO INDICATION OR REPORT FROM THE CUSTOME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306961 ↗
• MalfunctionJan 20, 2022False Negative Result; False Negative Result

  INTENDED USE: CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION OF YEASTS AND THE DIRECT IDENTIFICATION OF CANDIDA ALBICANS. THIS MEDIUM IS A MEDIUM FOR: THE SELECTIVE ISOLATION OF YEASTS, THE IDENTIFICATION OF THE SPECIES C. ALBICANS, THE PRESUMPTIVE DIFFERENTIATION OF A GROUP OF SPECIES COMPRISING C. TROPICALIS, C. LUSITANIAE AND C. KEFYR. DESCRIPTION: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING NO GROWTH FOR CANDIDA ALBICANS STRAINS FROM FIVE (5) PATIENTS IN ASSOCIATION WITH CHROMID® CANDIDA 20 PLATES (REF (B)(4), LOT 1009006390). THE STRAINS WERE COLLECTED FROM VAGINAL SWAB SAMPLES. THE CUSTOMER REPORTED THAT THE STRAINS DID NOT GROW ON THE CHROMID CANDIDA MEDIA, BUT DID GROW ON PVX MEDIA. THE STRAINS WERE ALL IDENTIFIED AS CANDIDA ALBICANS WITH THE BRUKER MALDI. THE GROWTH ISSUE WAS OBSERVED AT THE END OF THE CUSTOMER'S USE OF THIS BATCH AND THERE ARE NO LONGER ANY PLATES FROM THIS BATCH REMAINING AT THE CUSTOMER'S SITE. THE STRAINS WERE MANUALLY SEEDED ON A DIFFERENT BATCH OF CHROMID CANDIDA AND ONE (1) OR TWO (2) COLONIES GREW. THE CUSTOMER CONFIRMED THAT RESULTS WERE NOT DELAYED AND NO INCORRECT RESULTS WERE REPORTED. THERE IS NO INDICATION OR REPORT FROM THE CUSTOME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306951 ↗
• MalfunctionJan 20, 2022False Negative Result; False Negative Result

  INTENDED USE: CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION OF YEASTS AND THE DIRECT IDENTIFICATION OF CANDIDA ALBICANS. THIS MEDIUM IS A MEDIUM FOR: THE SELECTIVE ISOLATION OF YEASTS, THE IDENTIFICATION OF THE SPECIES C. ALBICANS, THE PRESUMPTIVE DIFFERENTIATION OF A GROUP OF SPECIES COMPRISING C. TROPICALIS, C. LUSITANIAE AND C. KEFYR. DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING NO GROWTH FOR CANDIDA ALBICANS STRAINS FROM FIVE (5) PATIENTS IN ASSOCIATION WITH CHROMID® CANDIDA 20 PLATES (REF 43631, LOT 1009006390). THE STRAINS WERE COLLECTED FROM VAGINAL SWAB SAMPLES. THE CUSTOMER REPORTED THAT THE STRAINS DID NOT GROW ON THE CHROMID CANDIDA MEDIA, BUT DID GROW ON PVX MEDIA. THE STRAINS WERE ALL IDENTIFIED AS CANDIDA ALBICANS WITH THE BRUKER MALDI. THE GROWTH ISSUE WAS OBSERVED AT THE END OF THE CUSTOMER'S USE OF THIS BATCH AND THERE ARE NO LONGER ANY PLATES FROM THIS BATCH REMAINING AT THE CUSTOMER'S SITE. THE STRAINS WERE MANUALLY SEEDED ON A DIFFERENT BATCH OF CHROMID CANDIDA AND ONE (1) OR TWO (2) COLONIES GREW. THE CUSTOMER CONFIRMED THAT RESULTS WERE NOT DELAYED AND NO INCORRECT RESULTS WERE REPORTED. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306928 ↗
• MalfunctionJan 20, 2022False Negative Result; False Negative Result

  INTENDED USE: CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION OF YEASTS AND THE DIRECT IDENTIFICATION OF CANDIDA ALBICANS. THIS MEDIUM IS A MEDIUM FOR: THE SELECTIVE ISOLATION OF YEASTS, THE IDENTIFICATION OF THE SPECIES C. ALBICANS, THE PRESUMPTIVE DIFFERENTIATION OF A GROUP OF SPECIES COMPRISING C. TROPICALIS, C. LUSITANIAE AND C. KEFYR. DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING NO GROWTH FOR CANDIDA ALBICANS STRAINS FROM FIVE (5) PATIENTS IN ASSOCIATION WITH CHROMID® CANDIDA 20 PLATES (REF 43631, LOT 1009006390). THE STRAINS WERE COLLECTED FROM VAGINAL SWAB SAMPLES. THE CUSTOMER REPORTED THAT THE STRAINS DID NOT GROW ON THE CHROMID CANDIDA MEDIA, BUT DID GROW ON PVX MEDIA. THE STRAINS WERE ALL IDENTIFIED AS CANDIDA ALBICANS WITH THE BRUKER MALDI. THE GROWTH ISSUE WAS OBSERVED AT THE END OF THE CUSTOMER'S USE OF THIS BATCH AND THERE ARE NO LONGER ANY PLATES FROM THIS BATCH REMAINING AT THE CUSTOMER'S SITE. THE STRAINS WERE MANUALLY SEEDED ON A DIFFERENT BATCH OF CHROMID CANDIDA AND ONE (1) OR TWO (2) COLONIES GREW. THE CUSTOMER CONFIRMED THAT RESULTS WERE NOT DELAYED AND NO INCORRECT RESULTS WERE REPORTED. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306919 ↗
• MalfunctionJan 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT IDENTIFICATION FOR A BLOOD CULTURE SAMPLE IN ASSOCIATION WITH CHROMID® CANDIDA AGAR (REF. 43631, LOT 1008930620, EXP DATE: 12/15/2021). THE CUSTOMER STATED THAT HE HAD DISCREPANT RESULTS BETWEEN : CAN2 (CHROMID CANDIDA), VITEK® 2 AND VITEK® MS FOR A BLOOD CULTURE SAMPLE. RESULT SUMMARY: CAN2 PLATE: SHOWED BLUE COLONIES OF C. ALBICANS, VITEK 2: C. PARAPSILOSIS, VITEK MS PRIME: LODDEROMYCES ELONGISPORUS. THE CUSTOMER BELIEVED THE CORRECT RESULT WAS THE VITEK 2 C. PARAPSILOSIS. 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 WILL INITIATE AN INTERNAL INVESTIGATION FOR THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13157056 ↗
• MalfunctionMar 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) REPORTED THAT HE OBSERVED NO GROWTH DURING A QUALITY CONTROL TEST WITH THE QC STRAIN CANDIDA ALBICANS ATCC 10231 ON CHROMID® CANDIDA AGAR (REF. (B)(4)). THE CUSTOMER REPORTED THAT THEY PERFORMED A QUANTITATIVE TEST WITH 10-100 CFU CANDIDA ALBICANS ATCC 10231 ON CHROM-ID-CANDIDA. THE ESTIMATED RECOVERY RATE SHOULD BE 50-200 % BUT THEY OBSERVED NO GROWTH. FOR DETECTION / QUALITATIVE ANALYSIS, NO ISSUE WAS OBSERVED. TO BE NOTED, THE QC DESCRIBED IN THE INSTRUCTION FOR USE DOES NOT INCLUDE AN ESTIMATED RECOVERY RATE, BUT A MICROBIAL ACTIVITY WITH GOOD GROWTH LEVEL. INDEED, ENUMERATION IS NOT IN THE INTENDED USE OF THE PRODUCT. THE CUSTOMER PERFORMS THE QUANTITATIVE TEST AS A DELIVERY CONTROL FOR EVERY LOT THEY RECEIVE. THE CUSTOMER STATED THAT USUALLY THE QUANTITATIVE TEST ALWAYS SHOWED LESS GROWTH, BUT NEVER NO GROWTH AS IT WAS OBSERVED THIS TIME. THERE IS NO PATIENT INVOLVED AS THIS EVENT OCCURRED DURING QUALITY CONTROL AND THIS IS AN INDUSTRY CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499834 ↗
• MalfunctionSep 24, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN HONG KONG NOTIFIED BIOMÉRIEUX OF INCORRECT COLONY COLOR IN ASSOCIATION WITH THE CHROMID® CANDIDA 20 PLATES (REF. (B)(4), LOT 1008173460) WHEN PERFORMING QUALITY CONTROL TESTING WITH ATCC® 9968¿ CANDIDA TROPICALIS. THE CUSTOMER INOCULATED ATCC® 9968¿ CANDIDA TROPICALIS ONTO LOT 1008173460 AND INCUBATED THE PLATES FOR FORTY-EIGHT (48) HOURS AND SEVENTY-TWO (72) HOURS PRIOR TO PERFORMING PLATE READING. THE CUSTOMER STATED THE COLONIES WERE PURPLISH PINK IN COLOR, CHROMID® CANDIDA 20 PLATES PACKAGE INSERT ¿QUALITY CONTROL¿ SECTION STATES THE EXPECTED RESULT FOR ATCC® 9968¿ CANDIDA TROPICALIS IS PINK. THE CUSTOMER ALSO TESTED ATCC® 10231¿ CANDIDA ALBICANS; THE EXPECTED RESULT OF BLUE COLONIES WAS OBSERVED. IT WAS CONFIRMED LOT 1008173460 HAD BEEN USED TO TEST PATIENT SAMPLES. HOWEVER, THERE IS NO EVIDENCE WHICH SUGGESTS AN INCORRECT RESULT WAS OBTAINED WHEN TESTING ANY PATIENT SAMPLE. ALL NON-CANDIDA ALBICANS PATIENT ISOLATES APPEARED PINK IN COLOR. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10579917 ↗
• MalfunctionSep 24, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF INCORRECT COLONY COLOR IN ASSOCIATION WITH THE CHROMID® CANDIDA 20 PLATES (REF. 43631, LOT 1008160410) WHEN PERFORMING QUALITY CONTROL TESTING WITH ATCC® 9968¿ CANDIDA TROPICALIS. THE CUSTOMER INOCULATED ATCC® 9968¿ CANDIDA TROPICALIS ONTO LOT 1008160410 AND INCUBATED THE PLATES FOR FORTY-EIGHT (48) HOURS AND SEVENTY-TWO (72) HOURS PRIOR TO PERFORMING PLATE READING. THE CUSTOMER STATED THE COLONIES WERE PURPLISH PINK IN COLOR, CHROMID® CANDIDA 20 PLATES PACKAGE INSERT ¿QUALITY CONTROL¿ SECTION STATES THE EXPECTED RESULT FOR ATCC® 9968¿ CANDIDA TROPICALIS IS PINK. THE CUSTOMER ALSO TESTED ATCC® 10231¿ CANDIDA ALBICANS; THE EXPECTED RESULT OF BLUE COLONIES WAS OBSERVED. IT WAS CONFIRMED LOT 1008160410 HAD BEEN USED TO TEST PATIENT SAMPLES, HOWEVER, THERE IS NO EVIDENCE WHICH SUGGESTS AN INCORRECT RESULT WAS OBTAINED WHEN TESTING ANY PATIENT SAMPLE. ALL NON-CANDIDA ALBICANS PATIENT ISOLATES APPEARED PINK IN COLOR. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10579434 ↗
• MalfunctionSep 24, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF INCORRECT COLONY COLOR IN ASSOCIATION WITH THE CHROMID® CANDIDA 20 PLATES (REF. 43631, LOT 1008152540) WHEN PERFORMING QUALITY CONTROL TESTING WITH ATCC® 9968¿ CANDIDA TROPICALIS. THE CUSTOMER INOCULATED ATCC® 9968¿ CANDIDA TROPICALIS ONTO LOT 1008152540 AND INCUBATED THE PLATES FOR FORTY-EIGHT (48) HOURS AND SEVENTY-TWO (72) HOURS PRIOR TO PERFORMING PLATE READING. THE CUSTOMER STATED THE COLONIES WERE PURPLISH PINK IN COLOR, CHROMID® CANDIDA 20 PLATES PACKAGE INSERT ¿QUALITY CONTROL¿ SECTION STATES THE EXPECTED RESULT FOR ATCC® 9968¿ CANDIDA TROPICALIS IS PINK. THE CUSTOMER ALSO TESTED ATCC® 10231¿ CANDIDA ALBICANS; THE EXPECTED RESULT OF BLUE COLONIES WAS OBSERVED. IT WAS CONFIRMED LOT 1008152540 HAD BEEN USED TO TEST PATIENT SAMPLES, HOWEVER, THERE IS NO EVIDENCE WHICH SUGGESTS AN INCORRECT RESULT WAS OBTAINED WHEN TESTING ANY PATIENT SAMPLE. ALL NON-CANDIDA ALBICANS PATIENT ISOLATES APPEARED PINK IN COLOR. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10579414 ↗
• MalfunctionAug 13, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FAINT COLOR WHEN PERFORMING QUALITY CONTROL TESTING WITH ATCC® STRAINS ON CHROMID CANDIDA 20 PLATES (REF (B)(4), LOT 1008005050). THE CUSTOMER REPORTED THAT THEY OBSERVED SLIGHTLY BLUE (ALMOST WHITE) COLONIES WHEN GROWING A CANDIDA ALBICANS ATCC STRAIN INSTEAD OF BLUE. THEY ALSO OBSERVED WHITE COLONIES WHEN GROWING A CANDIDA TROPICALIS ATCC STRAIN WHILE THEY SHOULD APPEAR PINK. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS LOT WAS USED BY THIS CUSTOMER TO TEST PATIENT SAMPLES. THE COMPLAINT ONLY INDICATES THAT TESTING WAS PERFORMED WITH ATCC STRAINS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 10403605 ↗
• MalfunctionApr 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING IRREGULAR GROWTH OF CANDIDA ALBICANS WHILE USING THE CHROMID® CANDIDA AGAR PLATE (REF. 43631). THE LOT NUMBER HAS NOT BEEN PROVIDED. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9974183 ↗
• MalfunctionDec 6, 2019False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING IRREGULAR GROWTH OF CANDIDA ALBICANS WHEN TESTING CLINICAL SAMPLES WITH THE CHROMID® CANDIDA AGAR PLATE (REF. 43631, LOT 1007562620). THE CUSTOMER REPORTED THAT THE GROWTH OF CANDIDA ALBICANS WAS NORMAL ON BLOOD AGAR AS COMPARED TO "NO", "SCANTY", AND "IRREGULAR SHAPED" COLONIES ON THE CANDIDA AGAR. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9428588 ↗
• MalfunctionDec 6, 2019False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING IRREGULAR GROWTH OF CANDIDA ALBICANS WHEN TESTING CLINICAL SAMPLES WITH THE CHROMID® CANDIDA AGAR PLATE (REF. 43631, LOT 1007462580). THE CUSTOMER REPORTED THAT THE GROWTH OF CANDIDA ALBICANS WAS NORMAL ON BLOOD AGAR AS COMPARED TO "NO", "SCANTY", AND "IRREGULAR SHAPED" COLONIES ON THE CANDIDA AGAR. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9428401 ↗
• MalfunctionDec 6, 2019False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING IRREGULAR GROWTH OF CANDIDA ALBICANS WHEN TESTING CLINICAL SAMPLES WITH THE CHROMID® CANDIDA AGAR PLATE (REF. 43631, LOT 1007494920). THE CUSTOMER REPORTED THAT THE GROWTH OF CANDIDA ALBICANS WAS NORMAL ON BLOOD AGAR AS COMPARED TO "NO", "SCANTY", AND "IRREGULAR SHAPED" COLONIES ON THE CANDIDA AGAR. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9428398 ↗
• MalfunctionDec 6, 2019False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING IRREGULAR GROWTH OF CANDIDA ALBICANS WHEN TESTING CLINICAL SAMPLES WITH THE CHROMID® CANDIDA AGAR PLATE (REF. 43631, LOT 1007445800). THE CUSTOMER REPORTED THAT THE GROWTH OF CANDIDA ALBICANS WAS NORMAL ON BLOOD AGAR AS COMPARED TO "NO", "SCANTY", AND "IRREGULAR SHAPED" COLONIES ON THE CANDIDA AGAR. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9428381 ↗
• MalfunctionNov 6, 2019False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF NOT OBTAINING GROWTH FOR A PATIENT CANDIDA ALBICANS ISOLATE FROM A VAGINAL SWAB PLATED ONTO CHROMID® CANDIDA 20 PLATES MEDIA (REFERENCE 43631, LOT 1007462580). THE CUSTOMER CONFIRMED THE PATIENT SAMPLE WAS PLATED ONTO COLUMBIA (COS) MEDIA IN PARALLEL WITH THE CHROMID CANDIDA MEDIA, LOT 1007462580. THE ISOLATE WAS ALSO REPEATED ON CHROMID CANDIDA MEDIA USING LOT 1007582260. BOTH THE COS MEDIA AND CHROMID CANDIDA MEDIA LOT 1007582260 WERE POSITIVE FOR GROWTH OF CANDIDA. THE CUSTOMER CONFIRMED THE DISCREPANT RESULT HAD NO ADVERSE EFFECT TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9288346 ↗
• MalfunctionAug 30, 2019False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED LOW GROWTH FOR A PATIENT SAMPLE FROM A VAGINAL SWAB, ON CHROMID® CANDIDA (CAN2) (REFERENCE (B)(4), LOT 1007436560). THE SAMPLE WAS POSITIVE ON MICROSCOPIC EXAMINATION FOR YEAST CELLS, BUT ONLY A FEW COLONIES GREW ON CAN2 PLATES AFTER 48 HOURS INCUBATION. THE CUSTOMER ALSO SWABBED THE SAMPLE ON PVX AND ANC AGAR; BOTH AGAR TYPES WERE POSITIVE FOR COLONY GROWTH. THE CUSTOMER REPORTED A DELAY GREATER THAN TWENTY-FOUR (24) HOURS BETWEEN THE TIME WHEN THE INITIAL RESULTS SHOULD HAVE BEEN REPORTED. 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 Known Impact Or Consequence To Patient

  MAUDE report 8952299 ↗
• MalfunctionFeb 27, 2019False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE (B)(6)CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF LITTLE/NO GROWTH (FALSE NEGATIVE) FOR A CANDIDA ALBICANS STRAIN IN ASSOCIATION WITH THE CHROMID® CANDIDA MEDIA. THE PATIENT ISOLATE WAS CONFIRMED AS CANDIDA ALBICANS VIA MALDI-TOF TEST METHOD. THE CUSTOMER STATED THAT NO INCORRECT RESULT WAS REPORTED TO THE TREATING PHYSICIAN, AND THAT NO PATIENT HARM OR INAPPROPRIATE TREATMENT OCCURRED. THE CUSTOMER INDICATED A DELAY OF >24 HOURS TO REPORT A RESULT DUE TO ADDITIONAL TESTING REQUIRED. THE CUSTOMER INFORMED BIOMÉRIEUX THAT THE CHROMID CANDIDA PLATES ARE ROUTINELY LEFT IN THE LAB ON A RACK FOR ABOUT FIVE (5) HOURS DURING THE DAY AND THE LEFTOVER PLATES ARE RETURNED TO THE REFRIGERATOR. PER THE CHROMID CANDIDA AGAR (CAN2) INSTRUCTIONS FOR USE ....... THIS MEDIUM MUST NOT BE EXPOSED TO LIGHT OTHER THAN DURING THE INOCULATION AND READING STEPS. ALLOW REAGENTS TO COME TO ROOM TEMPERATURE IN THE DARK. INOCULATE THE SPECIMEN. IMMEDIATELY INCUBATE THE INVERTED PLATES IN THE DARK AT +37°C IN AEROBIC CONDITIONS. THE USER IS RESPONSIBLE FOR CHOOSING THE APPROPRIATE INCUBATION TEMPERATURE FOR THE INTENDED USE, IN ACCORDANCE WITH CURRENT STANDARDS. THE CULTURES ARE GENERALL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8375662 ↗
• MalfunctionFeb 7, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE (B)(6) REPORTED A FALSE NEGATIVE RESULT FOR A PATIENT SAMPLE FROM A GENITAL SWAB, ON CHROMID® CANDIDA (CAN2) (LOT 1006823440). THE SAMPLE WAS POSITIVE ON MICROSCOPIC EXAMINATION FOR YEAST CELLS, BUT THE CULTURE WAS NEGATIVE ON CAN2 PLATES AFTER 48 HOURS INCUBATION. THE MICROSCOPY EXAMINATION AND CULTURE ON CAN2 WERE REPEATED, ALONG WITH CULTURE ON SABC (SABOURAUD DEXTROSE AGAR CHLORAMPHENICOL - OXOID) MEDIA. THE MICROSCOPY WAS STILL POSITIVE FOR YEAST CELLS. THE SABC SHOWED HEAVY GROWTH OF CANDIDA SP. ONE BLUE COLONY WAS PRESENT ON THE CAN2 PLATE, AFTER 48 HOURS INCUBATION. ADDITIONAL TESTING WAS PERFORMED WITH CAN2 PLATES ALREADY IN USE, AND CAN2 PLATES THAT WERE TAKEN FROM BOXES IN THE COLD ROOM OF THE SAME LOT. THE CULTURE WAS ALSO REPEATED WITH SABC PLATES. THE REPEAT CULTURE DEMONSTRATED A HEAVY GROWTH OF CANDIDA SP. ON THE SABC PLATES. THE CUSTOMER OBTAINED JUST ONE BLUE COLONY ON THE CAN2 PLATE IN USE AND NO GROWTH ON THE NEWER CAN2 PLATE. THE TWO BLUE COLONIES WERE ISOLATED ON TWO DIFFERENT CAN2 PLATES WERE CONFIRMED AS CANDIDA SP. BY PERFORMING A WET PREPARATION AND THE OBSERVATION OF YEAST CELLS. THE CUSTOMER STATED THAT THE PATIENT RESULTS WERE NOT AFFE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8318908 ↗