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VITEK® 2 AST-GN83Recalls & 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

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03573026531065), received between Sep 14, 2018 and Sep 14, 2018 — classified as 2 malfunctions.

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

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

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings2

Patient problems

  • No Patient Involvement2

Recent adverse event reports

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

  • MalfunctionSep 14, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE RESISTANT RESULTS FOR CAP SURVEY STRAIN (D-08) WHEN TESTING WITH THE VITEK® 2 AST-GN83 TEST KIT. THE ALCALIGENES FAECALIS STRAIN TESTED FALSE RESISTANT (MIC >=128) FOR PIPERACILLIN/TAZOBACTAM USING GN83 LOT 6730642103. THE EXPECTED RESULT IS SUSCEPTIBLE. 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 HAS BEEN INITIATED.

    Patient problems: No Patient Involvement

    MAUDE report 7878572 ↗
  • MalfunctionSep 14, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE RESISTANT RESULTS FOR CAP SURVEY STRAIN (D-08) WHEN TESTING WITH THE VITEK® 2 AST-GN83 TEST KIT. THE ALCALIGENES FAECALIS STRAIN TESTED FALSE RESISTANT (MIC >=128) FOR PIPERACILLIN/TAZOBACTAM USING GN83 LOT 6730703103. THE EXPECTED RESULT IS SUSCEPTIBLE. 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 HAS BEEN INITIATED.

    Patient problems: No Patient Involvement

    MAUDE report 7878534 ↗

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Sources and updates

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