VITEK® 2 AST-GN67Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03573026530907), received between Apr 19, 2018 and Oct 19, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT SUSCEPTIBILITY RESULTS FOR CAP SURVEY STRAIN(D-08), ALCALIGENES FAECALIS, WHEN TESTING WITH THE VITEK® 2 AST-GN67 TEST KIT. ON INITIAL AND REPEAT TESTING, THE STRAIN TESTED FALSE RESISTANT (MIC >128) FOR PIPERACILLIN/TAZOBACTAM. THE EXPECTED RESULT FOR THIS UNGRADED SURVEY STRAIN 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 WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7986474 ↗
• MalfunctionOct 1, 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 A CAP SURVEY STRAIN (D-08) IN ASSOCIATION WITH THE VITEK® 2 AST-GN67 TEST KIT. THE ALCALIGENES FAECALIS STRAIN TESTED RESISTANT (MIC >=128) AND THE EXPECTED RESULT WAS SUSCEPTIBLE. UPON REPEAT TESTING USING VITEK AST-GN80, THE CUSTOMER OBTAINED A SUSCEPTIBLE RESULT (MIC <=4). A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7924840 ↗
• MalfunctionSep 24, 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-GN67 TEST KIT. THE ALCALIGENES FAECALIS STRAIN TESTED FALSE RESISTANT FOR PIPERACILLIN/TAZOBACTAM USING GN67 LOT 5870607403. UPON REPEAT TESTING, THE CUSTOMER OBTAINED A SUSCEPTIBLE RESULT, WHICH IS THE EXPECTED RESULT FOR THIS SURVEY STRAIN. 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 7902782 ↗
• MalfunctionAug 23, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED A FALSE SUSCEPTIBLE AMPICILLIN/SULBACTAM RESULT (MIC=8 S) FOR AN API SURVEY STRAIN (ESCHERICHIA COLI, ESBL) IN ASSOCIATION WITH THE VITEK® 2 AST-GN67 TEST KIT. THE EXPECTED RESULT WAS RESISTANT. THE CUSTOMER DID REPEAT THE TEST AND THE RESULT WAS THE SAME. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7810466 ↗
• MalfunctionApr 19, 2018False Negative Result; False Negative Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE ESBL RESULTS ASSOCIATED WITH VITEK®2 AST-GN67 TEST KIT(REFERENCE 413399). REPEAT TESTING WAS CONDUCTED ON THE ISOLATE BECAUSE THE LABORATORY TECHNICIANS WERE QUESTIONING THE AMINOGLYCOSIDE HIERARCHY RESULTS FOR GENTAMICIN AND AMIKACIN. THE GENTAMYCIN WAS INTERMEDIATE AND AMIKACIN WAS RESISTANT. THE MICROSCAN RESULTS STATED THE ISOLATE WAS AN ESBL WHICH WAS NOT REPORTED ON THE VITEK® INSTRUMENT. THE CUSTOMER REPEATED THE ISOLATE TESTING ON THE VITEK®2 AND MICROSCAN AND RECEIVED THE SAME RESULTS. THE CUSTOMER DID REPORT OUT ON AN ESBL POSITIVE ISOLATE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7442825 ↗

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-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
• Z-0833-2023 · Nov 9, 2022 · Open, Classified
  VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400