CHROMID® MRSA agarRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03573026552114), received between Nov 11, 2020 and Feb 17, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-0802-2023 · Root cause: Storage · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2021False Negative Result

  A CUSTOMER IN THE UNITED STATES REPORTED THE OCCURRENCE OF A (B)(6) RESULT FOR A (B)(6) PATIENT STRAIN WHEN USING CHROMID¿ (B)(6) AGAR (REF. 43841, LOT 1008438600). THE SOURCE OF THE STRAIN IS UNKNOWN (I.E. BLOOD, SKIN, ETC.). THE CUSTOMER REPORTED THAT WHEN THEY PLATED THE SAMPLE ON THE CHROMID¿ (B)(6) MEDIA, GROWTH WAS OBSERVED ON THE PLATE BUT IT DID NOT TURN GREEN AFTER 24 HOURS AS A (B)(6) STRAIN SHOULD. THE CUSTOMER ALSO TESTED THE STRAIN ON VITEK¿ 2 AND OBTAINED A (B)(6) IDENTIFICATION AND A OXACILLIN RESISTANT RESULT. THE CUSTOMER REPEATED THE TEST AND STILL OBTAINED (B)(6) RESULT ON CHROMID¿ (B)(6). THE INSTRUCTIONS FOR USE (IFU) STATE IN THE LIMITATIONS OF THE PRODUCT: "RARE (B)(6) STRAINS MAY GROW ON CHROMID¿ (B)(6) WITHOUT PRODUCING GREEN COLOR AT 24 HOURS." THERE IS NO INFORMATION FROM THE CUSTOMER THAT THIS EVENT LED TO A DELAY OF RESULT OR IMPACTED THE PATIENT STATE OF HEALTH. A BIOM¿RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11337080 ↗
• MalfunctionNov 11, 2020False Positive Result; False Positive Result

  ON 12-OCT-2020, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING GREEN COLONIES FOR A STAPHYLOCOCCUS HOMINIS STRAIN DURING DIAGNOSTIC TESTING OF A PATIENT SPECIMEN WITH CHROMID® (B)(6) 20 PLT US ¿ (REF. 43841; LOT 1008219170- EXP.DATE: 27OCT2020). THE CUSTOMER STATED THAT THE PATIENT HAD STAPHYLOCOCCUS AUREUS AND THIS S. HOMONIS ISOLATE BOTH GROWING FROM THE SAME CULTURE. THEY SUBCULTURED EACH COLONY TYPE TO TSAB AND CHROMID® (B)(6) AGAR AND OBSERVED A GROWTH ON BOTH AGAR. GROWTH COLONIES WERE GREEN ¿ THE NORMAL CHARACTERISTIC COLOR FOR MRSA USING CHROMID® PLATES. THE ORGANISM WAS CONFIRMED TO BE S. HOMINIS BY (B)(6). AS PER PRODUCT INSTRUCTIONS FOR USE: ¿THE FOLLOWING (B)(6) ORGANISM STAPHYLOCOCCUS HOMINIS MAY GROW ON CHROMID® (B)(6) BUT DO NOT PRODUCE GREEN PIGMENTED COLONIES AT 24 HOURS.¿ THE CUSTOMER CONFIRMED NO ERRONEOUS RESULTS WERE REPORTED. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10824293 ↗