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VITEK® 2 AST-GN80Recalls & reported problems

Biomerieux , Inc. · VITEK ® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026531034), received between Oct 10, 2018 and Oct 10, 2018 — 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.

2 other recalls cover devices cleared under the same FDA submission (K040845, K041982, K052311, K072038, K091899, 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.

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-0837-2023 · Root cause: Storage · Recall details · FDA record ↗

Most reported problems

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionOct 10, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    A CUSTOMER IN THE UNITED STATES REPORTED A FALSE RESISTANT PIPERACILLIN/TAZOBACTAM RESULT FOR AN ALCALIGENES FAECALIS CAP SURVEY STRAIN (D-08) IN ASSOCIATION WITH THE VITEK® 2 AST-GN80 TEST KIT. THE CUSTOMER STATED THEY HAD REPORTED A RESISTANT RESULT. AFTER LEARNING THE EXPECTED RESULT WAS SUSCEPTIBLE, THE CUSTOMER RETESTED THE SAMPLE AND OBTAINED A SUSCEPTIBLE RESULT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Patient problems: No Patient Involvement

    MAUDE report 7954386 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040845, K041982, K052311, K072038, K091899, 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-0838-2023 · Nov 9, 2022 · Open, Classified
    VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438

Other System, Test, Automated, Antimicrobial Susceptibility, Short Incubation devices

All System, Test, Automated, Antimicrobial Susceptibility, Short Incubation devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page