VITEK® 2 AST-GN66Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026530891), received between Jul 3, 2019 and Jul 3, 2019 — classified as 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K040845, K041982, 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.

• MalfunctionJul 3, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A FALSE RESISTANT ERTAPENEM FOR A PROTEUS MIRABILIS PATIENT URINE SAMPLE USING VITEK® 2 AST-GN66 TEST KIT IN DUPLICATE (REFERENCE #: 413398 LOT# : 5861021103). THE PROTEUS MIRABILIS STRAIN TESTED SUSCEPTIBLE, AND WAS THEN MODIFIED TO RESISTANT BY THE VITEK 2 ADVANCED EXPERT SYSTEM¿ (AES). THE ISOLATE WAS SENT TO A REFERENCE LAB FOR TESTING AND THE RESULTS WERE SUSCEPTIBLE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8758385 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040845, K041982, K072038, K103752, K110106, K113200, 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-0837-2023 · Nov 9, 2022 · Open, Classified
  VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
• Z-0838-2023 · Nov 9, 2022 · Open, Classified
  VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438