VITEK®2 AST-GP71Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026530655), received between Jun 20, 2017 and Jun 20, 2017 — 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.

3 other recalls cover devices cleared under the same FDA submission (K032399, K032738, K032766, K050976, K053097, K072668, K072695, K080201, K091126, N50510); they may or may not involve this specific model.

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. Jan 26, 2018Terminated

   Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.

   Z-2817-2018 · Root cause: Under Investigation by firm · 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.

• MalfunctionJun 20, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS INVOLVING S. AUREUS ASSOCIATED WITH VITEK®2 AST-GP71 TEST KIT. THE CUSTOMER REPORTED THEY HAD SEVENTEEN (17) CARDS WITH RESISTANT OXACILLIN AND REPEAT TESTING ON VITEK® 2 REPORTED THE RESULT AS SUSCEPTIBLE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6653437 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032399, K032738, K032766, K050976, K053097, K072668, K072695, K080201, K091126, N50510. One submission often covers many models, so check the product and lot details in each record.

• Z-0792-2023 · Nov 9, 2022 · Open, Classified
  VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226
• Z-0843-2023 · Nov 9, 2022 · Open, Classified
  VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670
• Z-1742-2020 · Mar 11, 2020 · Open, Classified
  The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcu