VITEK® 2 AST-GN73Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03573026530969), received between Aug 31, 2017 and Oct 15, 2018 — classified as 5 malfunctions.

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

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

2 other recalls cover devices cleared under the same FDA submission (K040845, 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. How this data works · Data updated Oct 13, 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-0835-2023 · Root cause: Storage · FDA record ↗

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 15, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES REPORTED A FALSE RESISTANT PIPERACILLIN/TAZOBACTAM RESULT FOR AN ALCALIGENES FAECALIS CAP D-08 SURVEY SAMPLE, WHEN USING THE VITEK® 2 AST-GN73 TEST KIT. THE CUSTOMER STATED THEY SUBMITTED A RESISTANT (MIC >=128) RESULT TO CAP AND LEARNED THE EXPECTED RESULT WAS SUSCEPTIBLE. THE CUSTOMER THEN REPEATED THE TEST AND THE RESULT WAS SUSCEPTIBLE (MIC <=4). A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7967025 ↗
• MalfunctionAug 31, 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 FOR AN ESCHERICHIA COLI ESBL POSITIVE API SURVEY STRAIN, IN ASSOCIATION WITH THE VITEK® 2 AST-GN73 TEST KIT (LOT 5930617403). THE CUSTOMER TWICE OBTAINED A SUSCEPTIBLE RESULT (MIC=8) FOR AMPICILLIN/SULBACTAM. THE EXPECTED RESULT FOR THIS SURVEY STRAIN WAS INTERMEDIATE/RESISTANT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7836985 ↗
• MalfunctionAug 31, 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 FOR AN ESCHERICHIA COLI ESBL POSITIVE API SURVEY STRAIN, IN ASSOCIATION WITH THE VITEK® 2 AST-GN73 TEST KIT (LOT 5930713203). THE CUSTOMER TWICE OBTAINED A SUSCEPTIBLE RESULT (MIC=8) FOR AMPICILLIN/SULBACTAM. THE EXPECTED RESULT FOR THIS SURVEY STRAIN WAS INTERMEDIATE/RESISTANT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7836983 ↗
• MalfunctionAug 27, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED A FALSE SUSCEPTIBLE CEFEPIME (MIC=2) RESULT FOR AN ESCHERICHIA COLI APR SURVEY STRAIN (UR-06, ESBL PHENOTYPE)) IN ASSOCIATION WITH THE VITEK® 2 AST-GN73 TEST KIT (LOT 5930611403). REPEAT TESTING ALSO GAVE A SUSCEPTIBLE RESULT, WHEN THE EXPECTED RESULT WAS RESISTANT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7818423 ↗
• MalfunctionAug 31, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE RESISTANT RESULTS WHEN TESTING SUSCEPTIBILITY OF ESCHERICHIA COLI TO MEROPENEM WITH VITEK® 2 AST-GN73 TEST KIT. CUSTOMER STATED INITIAL RESULT WAS RESISTANT. UPON REPEAT TESTING AND WITH KIRBY BAUER DISK SUSCEPTIBILITY TEST, CUSTOMER OBTAINED SUSCEPTIBLE MEROPENEM RESULT. CUSTOMER STATED THERE WAS A GREATER THAN 24 HOUR DELAY IN REPORTING PATIENT RESULTS. 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 HAS BEEN INITIATED. THE REFERENCED AST-GN73 CARD LOT IS INCLUDED IN THE FSCA-3445. THE CUSTOMER STATES SHE OBSERVED HOLES NEAR THE CRIMP ON POUCH. FIELD SAFETY CORRECTIVE ACTION (FSCA) 3445 WAS ISSUED ON 19APR2017 TO IMPACTED BIOMÉRIEUX SUBSIDIARIES AND DISTRIBUTORS TO NOTIFY CUSTOMERS OF THIS ISSUE AND COMMUNICATE MITIGATION ACTIVITIES TO BE IMPLEMENTED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6833787 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040845, K072038, 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-0833-2023 · Nov 9, 2022 · Open, Classified
  VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400