CHROMID® C. difficileRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03573026600075), received between Feb 23, 2018 and Aug 3, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (2 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-0804-2023 · Root cause: Storage · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2022False Negative Result; False Negative Result

  INTENDED USE: CHROMOGENIC MEDIUM FOR THE DETECTION AND IDENTIFICATION OF CLOSTRIDIUM DIFFICILE. THIS MEDIUM DOES NOT DISTINGUISH TOXIGENIC FROM NON-TOXIGENIC STRAINS OF C. DIFFICILE. THIS MEDIUM IS A SELECTIVE CHROMOGENIC MEDIUM FOR THE DETECTION AND IDENTIFICATION OF CLOSTRIDIUM DIFFICILE IN STOOL SAMPLES FROM SYMPTOMATIC PATIENTS. WITH THE USE OF ADDITIONAL TESTS THAT DETECT C. DIFFICILE TOXINS, THE MEDIUM CONTRIBUTES TO THE DIAGNOSIS AND EPIDEMIOLOGICAL MONITORING OF C. DIFFICILE INFECTIONS. CLOSTRIDIUM DIFFICILE IS A CAUSATIVE AGENT OF PSEUDOMEMBRANOUS COLITIS AND MORE GENERALLY OF NOSOCOMIAL OR ANTIBIOTIC ASSOCIATED DIARRHEA. THIS MEDIUM CAN ALSO BE USED FOR ENVIRONMENTAL CONTROL. ISSUE DESCRIPTION: A CUSTOMER IN THE REPUBLIC OF KOREA NOTIFIED BIOMÉRIEUX OF CLOSTRIDIUM DIFFICILE FALSE NEGATIVE RESULT IN ASSOCIATION WITH CHROMID C.DIFFICILE 20 PLT (REF. 43871, LOT 1009326410, EXPIRATION DATE 25-JUL-2022). IT WAS REPORTED THAT SAMPLES WERE IDENTIFIED AS CLOSTRIDIUM DIFFICILE USING BRUKER'S MALDI-TOF. THE RESULTS WERE VERIFIED USING CHROMID CDIF. HOWEVER, THE COLONIES GREW INTO WHITE COLONIES RATHER THAN GRAYISH-BLACK COLONIES. ACCORDING TO BIOMÉRIEUX GLOBAL CUSTOMER SERVICE (GCS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15157703 ↗
• MalfunctionMar 13, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED A RESULT OF NO GROWTH, FOR A CLOSTRIDIUM DIFFICILE QUALITY CONTROL (QC) STRAIN (B)(4)), IN ASSOCIATION WITH CHROMID¿ C. DIFFICILE AGAR. THE CUSTOMER STATED THEY INOCULATED A NEW LOT OF CHROMID¿ C. DIFFICILE AGAR (LOT 1006170510) WITH THE QC STRAIN, AND HAD OBSERVED NO BACTERIAL GROWTH AFTER INCUBATION AT 36 °C (+/- 1°C) IN ANAEROBIC ATMOSPHERE (GENERATED BY ANAEROBIC JARS). THE CUSTOMER STATED THAT THEY PERFORM THE QC TEST FOR EACH NEW LOT, AND THAT CLINICAL SAMPLES WERE NOT INOCULATED ON THIS LOT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7334715 ↗
• MalfunctionFeb 23, 2018False Negative Result; False Negative Result

  A VETERINARY CUSTOMER FROM (B)(6) REPORTED NO GROWTH ON CHROMID® C. DIFFICILE (LOT 1006045090) WHILE CONDUCTING AN EXPERIMENT. THE CUSTOMER STATED THE EXPERIMENT WAS REPEATED USING THE CUSTOMER'S MEDIA (BHISS WITH ADDED C. DIFF SUPPLEMENT) AND THE CHROMID PLATES. RESULTS WERE OBTAINED WITH THE CUSTOMER'S MEDIA BUT NOT WITH THE CHROMID. THE SAMPLES BEING TESTED WERE FECAL SPECIMENS FROM ANIMALS THAT WERE INFECTED WITH THE C. DIFFICILE 630 STRAIN. THE CUSTOMER REPORTED THAT SAMPLES WITH THE C. DIFFICILE 630 STRAIN ALWAYS GREW WELL ON PREVIOUS LOTS OF CHROMID SO A REFERENCE STRAIN WAS NOT USED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED. ALTHOUGH THIS EVENT INVOLVED ANIMAL TESTING, THE PRODUCT CHROMID C. DIFFICILE , CAN BE USED IN A CLINICAL SETTING AND THE SITUATION OF NO GROWTH CAN RECUR WHILE TESTING A PATIENT ISOLATE.

  Patient problems: No Patient Involvement

  MAUDE report 7291954 ↗