VITEK® 2 AST-GN95Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03573026563844), received between Sep 20, 2018 and Sep 20, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

3 other recalls cover devices cleared under the same FDA submission (K040845, K072038, K103752, K110106, K113200, K152075, K161217, K161227, 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. Mar 14, 2024Open, Classified

   Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.

   Z-1464-2024 · Root cause: Employee error · FDA record ↗

2. Nov 9, 2022Open, Classified

   As the temperature and time out of range was exceeded, product performances cannot be guaranteed

   Z-0853-2023 · Root cause: Storage · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE RESISTANT CEFTRIAXONE RESULTS OBTAINED ON A CAP SURVEY STRAIN (CITROBACTER BRAAKII) WHEN TESTING WITH THE VITEK® 2 AST-GN95 TEST KIT, LOT 6850485403. THE RESISTANT CEFTRIAXONE RESULT WAS OBTAINED WITH INITIAL AND REPEAT TESTING. THE EXPECTED RESULT WAS SUSCEPTIBLE. WHEN THE CUSTOMER RECEIVED THE SURVEY RESULTS, SHE TESTED WITH MICROSCAN AND OBTAINED SUSCEPTIBLE RESULTS. THE CUSTOMER DID REPEAT TESTING ON (B)(6) 2018 AND OBTAINED A SUSCEPTIBLE RESULT. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7893636 ↗
• MalfunctionSep 20, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE RESISTANT RESULTS FOR A CAP SURVEY STRAIN (D-08) WHEN TESTING WITH THE VITEK® 2 AST-GN95 TEST KIT. THE ALCALIGENES FAECALIS STRAIN TESTED FALSE RESISTANT (MIC >=128) FOR PIPERACILLIN/TAZOBACTAM USING THE AST-GN95 CARD, LOT 6850485403. THE EXPECTED RESULT IS SUSCEPTIBLE. THE CUSTOMER DID REPEAT TESTING AND STILL OBTAINED RESISTANT RESULTS (MIC >/=128) WITH THE SAME LOT. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7893634 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040845, K072038, K103752, K110106, K113200, K152075, K161217, K161227, N50510. One submission often covers many models, so check the product and lot details in each record.

• Z-0833-2023 · Nov 9, 2022 · Open, Classified
  VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400
• Z-0861-2023 · Nov 9, 2022 · Open, Classified
  VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829
• Z-0837-2023 · Nov 9, 2022 · Open, Classified
  VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437