VITEK® 2 AST-GN70Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03573026530938), received between Jul 30, 2018 and Sep 27, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K040845, K041982, K052311, 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-0834-2023 · Root cause: Storage · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 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 TRIMETHOPRIM/SULFAMETHOXAZOLE RESULTS WHEN TESTING WITH THE VITEK ® 2 AST-GN70 TEST KIT (REF 413401, LOT 5900663403). A PATIENT'S TRACHEAL ASPIRATE SAMPLE WAS IDENTIFIED AS STENOTROPHOMONAS MALTOPHILIA. SUSCEPTIBILITY TESTING ON THE AST-GN70 OBTAINED A RESISTANT RESULT (MIC = 80) ON INITIAL TESTING WITH LOT 5900663403 AND REPEAT TESTING ON LOT 5900755403. THE PHYSICIAN QUESTIONED THE RESISTANT RESULT; THEREFORE, THE STRAIN WAS SENT TO ANOTHER LAB FOR TESTING. THE EXTERNAL LAB USED MICROSCAN AND OBTAINED A SUSCEPTIBLE RESULT (MIC <= 2/38). 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 7915660 ↗
• MalfunctionSep 27, 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 TRIMETHOPRIM/SULFAMETHOXAZOLE RESULTS WHEN TESTING WITH THE VITEK ® 2 AST-GN70 TEST KIT (REF 413401, LOT 5900755403). A PATIENT'S TRACHEAL ASPIRATE SAMPLE WAS IDENTIFIED AS STENOTROPHOMONAS MALTOPHILIA. SUSCEPTIBILITY TESTING ON THE AST-GN70 OBTAINED A RESISTANT RESULT (MIC = 80) ON INITIAL TESTING WITH LOT 5900663403 AND REPEAT TESTING ON LOT 5900755403. THE PHYSICIAN QUESTIONED THE RESISTANT RESULT; THEREFORE, THE STRAIN WAS SENT TO ANOTHER LAB FOR TESTING. THE EXTERNAL LAB USED MICROSCAN AND OBTAINED A SUSCEPTIBLE RESULT (MIC <= 2/38). 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 7915654 ↗
• MalfunctionSep 27, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 AST-GN70 TEST KIT (REFERENCE 413401). THE CUSTOMER REPORTED RECEIVING AN INCORRECT RESULT ON THE API SURVEY. ON AN ESCHERICHIA COLI ISOLATE, AMPICILLIN/SULBACTAM AND CEFEPIME WERE REPORTED AS SENSITIVE. THE EXPECTED RESULTS FOR THESE DRUGS WERE INTERMEDIATE OR RESISTANT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7914599 ↗
• MalfunctionSep 27, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 AST-GN70 TEST KIT (REFERENCE 413401). THE CUSTOMER REPORTED RECEIVING AN INCORRECT RESULT ON THE API SURVEY. ON AN ESCHERICHIA COLI ISOLATE, AMPICILLIN/SULBACTAM AND CEFEPIME WERE REPORTED AS SENSITIVE. THE EXPECTED RESULTS FOR THESE DRUGS WERE INTERMEDIATE OR RESISTANT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7914595 ↗
• 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 DISCREPANT SUSCEPTIBILITY RESULTS FOR CAP SURVEY STRAIN (D-08) WHEN TESTING WITH THE VITEK® 2 AST-GN70 TEST KIT. THE EXPECTED RESULT FOR THIS UNGRADED SURVEY ALCALIGENES FAECALIS STRAIN IS SUSCEPTIBLE. ON INITIAL TESTING, THE STRAIN TESTED FALSE RESISTANT (MIC >=128) FOR PIPERACILLIN/TAZOBACTAM USING VITEK 2 AST-GN70, LOT 5900678403. 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 7903831 ↗
• MalfunctionJul 30, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED FALSE SUSCEPTIBLE ERTAPENEM RESULTS FOR TWO KLEBSIELLA PNEUMONIAE STRAINS FROM ONE PATIENT, IN ASSOCIATION WITH THE VITEK® 2 AST-GN70 TEST KIT (LOT 5900705403). THE CUSTOMER REPORTED THAT THE ERTAPENEM WAS SUSCEPTIBLE WITH INITIAL TESTING (MIC= <=0.5). UPON REPEAT TESTING ERTAPENEM TESTED RESISTANT (MIC=2 WITH NEW LOWERED CARBAPENEM BREAKPOINTS). ERTAPENEM DISC TESTING WAS RESISTANT WITH ZONE SIZE OF 15 MM. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX 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 7732828 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040845, K041982, K052311, K091899, 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