CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep bloodRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03573026600426), received between Jan 15, 2021 and Mar 29, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 reports).

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 18, 2026.

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.

• MalfunctionMar 29, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMRIEUX OF A CONTAMINATION WITH BACTERIA ON THE MULTIMEDIA CHROMID CPS ELITE AGAR/COLUMBIA CNA AGAR + 5% SHEEP BLOOD PLATES  REFERENCE 418229  LOT #1008372870. THE CUSTOMER FIRST OBSERVED THE CONTAMINATION AFTER LOCAL STORAGE, AND THEN CHECKED THE MEDIA AFTER USING IT AND NOTICED SOME CONTAMINATION AFTER USE. THE CUSTOMER STATED THE CONTAMINATION WAS INSIDE THE AGAR AND ON THE SURFACE. THE IDENTIFICATION OF THE BACTERIA IS NOT KNOWN. THE CUSTOMER CONFIRMED THAT NO ERRONEOUS PATIENT RESULTS OR DELAYED RESULTS WERE REPORTED DUE TO THE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585876 ↗
• MalfunctionJan 15, 2021Contamination /Decontamination Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT HE OBSERVED CONTAMINATION WITH BACTERIA ON THE MULTIMEDIA CHROMID® CPS® ELITE AGAR/COLUMBIA CNA AGAR + 5% SHEEP BLOOD PLATES (REF. 418229; LOT 1008372870). THE CUSTOMER OBSERVED THE CONTAMINATION BEFORE USE, BUT IN SOME SAMPLES IT WASN¿T NOTICED UNTIL AFTER INOCULATION. THE IDENTIFICATION OF THE BACTERIA IS NOT KNOWN. THE CUSTOMER REPORTED HE OBSERVED THE ISSUE CONTINUOUSLY THROUGH THE ENTIRE LOT WHICH GIVES A TOTAL OF 65-75 CONTAMINATED PLATES. CUSTOMER HAS NOW STARTED ON ANOTHER LOT AND DOES NOT SEE THIS PROBLEM ANYMORE. SOME SAMPLES WERE DELAYED ONE DAY BECAUSE THE CONTAMINATION WAS NOT NOTICED UNTIL AFTER THE INOCULATION AND THEREFORE DEMANDED AN RE-INOCULATION DUE TO OTHER (REAL) GROWTH OBSERVED. SOME OTHER SAMPLES THAT HAD NO GROWTH AT ALL OTHER THAN THE ONE CONTAMINATION-COLONY (EASILY RECOGNIZED) WERE REPORTED AS NORMAL AND THEREFORE NOT DELAYED. NO FALSE RESULTS REPORTED. THERE IS NO INDICATION FROM THE CUSTOMER THAT THIS EVENT IMPACTED THE PATIENTS STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WAS PERFORMED. THE CONTAMINATION WAS REPORTED AS BEING ON THE SURFACE AND/OR IN THE MASS OF THE PRODUCT. THE CUSTOMER SUBMITTED SEVERAL P

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11181325 ↗