VITEK® 2 AST-GN77Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026531003), received between Oct 11, 2018 and Oct 11, 2018 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K041982, K052311, K072038, K103752, K110106, K113200, 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A FALSE SUSCEPTIBLE CEFEPIME (MIC = 2) RESULT FOR AN API SURVEY SAMPLE (UR-06 ESCHERICHIA COLI) IN ASSOCIATION WITH THE VITEK® AST-GN77 TEST KIT. THE EXPECTED RESULT FOR THE SURVEY WAS CEFEPIME RESISTANT. THE CUSTOMER NO LONGER HAS THE API STRAIN IN THEIR POSSESSION. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR A PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE API SURVEY STRAIN. BIOMÉRIEUX REQUESTED STRAIN SUBMITTAL FROM THE CUSTOMER; HOWEVER, THE STRAIN IS NO LONGER AVAILABLE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7957990 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041982, K052311, K072038, K103752, K110106, K113200, N50510. One submission often covers many models, so check the product and lot details in each record.

• Z-0838-2023 · Nov 9, 2022 · Open, Classified
  VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438