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API® 50 CHRecalls & reported problems

Biomerieux SA · API 50 CH combines 50 biochemical tests for ID of Lactobacillus and related genera as well as Bacillus and related genera, Enterobacteriaceae and Vibrionaceae. · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026588694), received between May 11, 2021 and May 11, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

1 FDA recall record name this device's identifier.

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. Sep 30, 2021Terminated

    There is potential to provide an incorrect organism identification.

    Z-0243-2022 · Root cause: Material/Component Contamination · FDA record ↗

Most reported problems

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 11, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    ON THE 13TH OF APRIL 2021, A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX THAT THEY HAVE OBTAINED A POTENTIAL FALSE POSITIVE RESULT WITH THE PRODUCT API 50 CH 10STRIPS (REF 50300, BATCH 1008511380, EXPIRY DATE 13-OCT-2021). THE CUSTOMER SAID HE OBSERVED ORANGE COLORATION POST-INCUBATION EVEN IN THE ABSENCE OF BACTERIA. IT WAS REPORTED THAT THE CUSTOMER TESTED API 50 CH WITH AEROBIC AND ANAEROBIC ORGANISMS. HE READ AT 24/48 AND 72 HOURS FOR AEROBIC ORGANISMS AND 48/72 HOURS FOR ANAEROBIC ORGANISMS, AND RESULTS WERE THE SAME WITH AND WITHOUT BACTERIA. THE METHODOLOGY WAS CONFIRMED, MCF IS ACCEPTABLE AS INDICATED IN THE TECHNICAL SHEET, USE OF THE DENSIMAT STORAGE OK 2/8 °C. 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 11809115 ↗

Other CULTURE MEDIA, GENERAL NUTRIENT BROTH devices

All CULTURE MEDIA, GENERAL NUTRIENT BROTH devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.