VITEK® MS-DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026554224), received between Feb 16, 2021 and Feb 16, 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, 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-0814-2023 · Root cause: Storage · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionFeb 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF ESCHERICHIA COLI AS SALMONELLA WHEN TESTING A SAMPLE WITH VITEK® MS-DS (REF. 410893) ¿ LOT 11111256BM USED IN ASSOCIATION WITH VITEK® MS INSTRUMENT (REF. 410895) ¿ SERIAL NUMBER (B)(4). THE CUSTOMER REPORTED HE OBTAINED SALMONELLA, 99.4% DURING INITIAL TESTING. THE CUSTOMER PERFORMED AN ANTIBIOTIC SUSCEPTIBILITY TEST AND REPORTED THAT THE RESULTS DID NOT CORRELATE TO A SALMONELLA IDENTIFICATION. HE RETESTED THE SAMPLE VIA VITEK® MS AND OBTAINED ESCHERICHIA COLI. THE RESULT OF THE FIRST IDENTIFICATION (SALMONELLA) WAS REPORTED TO THE CLINICIAN. HOWEVER, THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11331697 ↗