chromID™ Salmonella AgarRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03573026600839), received between Dec 11, 2019 and May 6, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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 16, 2026.

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.

• MalfunctionMay 6, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, AN (B)(6) CUSTOMER REPORTED ATYPICAL COLORATION WHEN TESTING SALMONELLA STRAIN WITH CHROMID SALMONELLA 20 PLATES - REFERENCE 43621, LOT 1007807000, EXPIRY DATE 22-MAY-2020. THE CUSTOMER DIDN'T OBTAIN THE CORRECT CHARACTERISTIC COLONY COLOR ON 3 DIFFERENT SAMPLES. 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 10028255 ↗
• MalfunctionDec 27, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF NO GROWTH OBSERVED FOR A SALMONELLA BREDENEY STRAIN WHEN TESTING AN EXTERNAL QC STRAIN WITH CHROMID® SALMONELLA PLATES (REF 43621, LOT 1007614530). AS THIS WAS AN EXTERNAL QC SAMPLE, THERE IS NO PATIENT INVOLVED. THE CUSTOMER STATED THAT NO GROWTH WAS OBSERVED WHEN TESTING THE PROFICIENCY STRAIN ON CHROMID® SALMONELLA AGAR WHILE PCR GAVE A POSITIVE RESULT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 9527629 ↗
• MalfunctionDec 11, 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 OBTAINING FALSE NEGATIVE RESULTS WHEN TESTING WITH THE CHROMID® SALMONELLA (20 PLATES) AGAR (REF. 43621, LOT 1007376340). THE CUSTOMER REPORTED GROWTH OF UNCHARACTERISTIC WHITE COLONIES ON THE AGAR. NO PALE PINK COLONIES WERE NOTED. THE CUSTOMER WAS PERFORMING CONFIRMATORY TESTING WITH A POWDER SAMPLE COLLECTED FROM SOIL AND EQUIPMENT AT A DAIRY SITE. THERE IS NO PATIENT ASSOCIATED WITH THE TESTED SAMPLE. THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH DUE TO THESE DISCREPANT RESULTS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 9452061 ↗