VITEK® 2 AST-GN81Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03573026531041), received between Jun 29, 2017 and Dec 3, 2018 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (5 reports).

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

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-0838-2023 · Root cause: Storage · Recall details · 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.

• MalfunctionDec 3, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED FALSE RESISTANT CARBAPENEMS IN ASSOCIATION WITH THE VITEK® 2 AST-GN81 TEST KIT (LOT 6710736203). THE CUSTOMER REPORTED THAT FALSE RESISTANT ERTAPENEM AND MEROPENEM RESULTS WERE OBTAINED FOR TWO (2) ESCHERICHIA COLI PATIENT STRAINS, WITH LOT 6710736203. RETESTING WITH NEW LOT 6710840403 GAVE SUSCEPTIBLE RESULTS. ETEST® FOR ERTAPENEM AND MEROPENEM GAVE SUSCEPTIBLE RESULTS. PATIENT 1: LOT 6710736203 - ERTAPENEM MIC >=8 R; MEROPENEM MIC >=16 R, LOT 6710840403 - ERTAPENEM MIC <=0.5 S; MEROPENEM MIC <=0.25 S. PATIENT 2: LOT 6710736203 - ERTAPENEM MIC >=8 R; MEROPENEM MIC >=16 R, LOT 6710840403 - ERTAPENEM MIC <=0.5 S; MEROPENEM MIC <=0.25 S. NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. 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 8126949 ↗
• MalfunctionDec 3, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED FALSE RESISTANT CARBAPENEMS IN ASSOCIATION WITH THE VITEK® 2 AST-GN81 TEST KIT (LOT 6710736203). THE CUSTOMER REPORTED THAT FALSE RESISTANT ERTAPENEM AND MEROPENEM RESULTS WERE OBTAINED FOR TWO (2) ESCHERICHIA COLI PATIENT STRAINS, WITH LOT 6710736203. RETESTING WITH NEW LOT 6710840403 GAVE SUSCEPTIBLE RESULTS. ETEST® FOR ERTAPENEM AND MEROPENEM GAVE SUSCEPTIBLE RESULTS. PATIENT 1: LOT 6710736203 - ERTAPENEM MIC >=8 R; MEROPENEM MIC >=16 R, LOT 6710840403 - ERTAPENEM MIC <=0.5 S; MEROPENEM MIC <=0.25 S. PATIENT 2: LOT 6710736203 - ERTAPENEM MIC >=8 R; MEROPENEM MIC >=16 R, LOT 6710840403 - ERTAPENEM MIC <=0.5 S; MEROPENEM MIC <=0.25 S. NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. 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 8126943 ↗
• MalfunctionDec 3, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED FALSE RESISTANT CARBAPENEMS IN ASSOCIATION WITH THE VITEK® 2 AST-GN81 TEST KIT (LOT 6710736203). THE CUSTOMER REPORTED THAT FALSE RESISTANT ERTAPENEM AND MEROPENEM RESULTS WERE OBTAINED FOR TWO (2) ESCHERICHIA COLI PATIENT STRAINS, WITH LOT 6710736203. RETESTING WITH NEW LOT 6710840403 GAVE SUSCEPTIBLE RESULTS. ETEST® FOR ERTAPENEM AND MEROPENEM GAVE SUSCEPTIBLE RESULTS. PATIENT 1: LOT 6710736203 - ERTAPENEM MIC >=8 R; MEROPENEM MIC >=16 R, LOT 6710840403 - ERTAPENEM MIC <=0.5 S; MEROPENEM MIC <=0.25 S. PATIENT 2: LOT 6710736203 - ERTAPENEM MIC >=8 R; MEROPENEM MIC >=16 R, LOT 6710840403 - ERTAPENEM MIC <=0.5 S; MEROPENEM MIC <=0.25 S. NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. 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 8126942 ↗
• MalfunctionDec 3, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED FALSE RESISTANT CARBAPENEMS IN ASSOCIATION WITH THE VITEK® 2 AST-GN81 TEST KIT (LOT 6710736203). THE CUSTOMER REPORTED THAT FALSE RESISTANT ERTAPENEM AND MEROPENEM RESULTS WERE OBTAINED FOR TWO (2) ESCHERICHIA COLI PATIENT STRAINS, WITH LOT 6710736203. RETESTING WITH NEW LOT 6710840403 GAVE SUSCEPTIBLE RESULTS. ETEST® FOR ERTAPENEM AND MEROPENEM GAVE SUSCEPTIBLE RESULTS. PATIENT 1: LOT 6710736203 - ERTAPENEM MIC >=8 R; MEROPENEM MIC >=16 R; LOT 6710840403 - ERTAPENEM MIC <=0.5 S; MEROPENEM MIC <=0.25 S. PATIENT 2: LOT 6710736203 - ERTAPENEM MIC >=8 R; MEROPENEM MIC >=16 R; LOT 6710840403 - ERTAPENEM MIC <=0.5 S; MEROPENEM MIC <=0.25 S. NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. 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 8126940 ↗
• InjuryJun 29, 2017Incorrect, 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-GN81 TEST KIT. THE CUSTOMER REPORTED THAT OVER A WEEKEND THEY HAD 6 - 8 INSTANCES WHERE ENTEROBACTERIACEAE HAD ELEVATED ERTA OR MEROPENEM MICS ON THE VITEK®2 INSTRUMENT THAT WERE COMPLETELY SUSCEPTIBLE BY DISK DIFFUSION. THE CUSTOMER EXPLAINED THAT MOST OF THE OTHER BETA-LACTAMS WERE ALSO SUSCEPTIBLE ON THE VITEK® 2 INSTRUMENT, WHICH TO THEM INDICATED THIS IS A POTENTIAL CARD ISSUE. ALL CARD PACKAGING WAS CHECKED ACCORDING TO BIOMÉRIEUX RECOMMENDATIONS AND NO HOLES WERE FOUND IN THE PACKAGING. ONE INCORRECT RESULT WAS REPORTED TO THE PHYSICIAN. A PATIENT WAS DISCHARGED BUT MAY HAVE BEEN GIVEN STRONGER ANTIBIOTICS THAN SHE ACTUALLY NEEDED.

  Patient problems: Misdiagnosis

  MAUDE report 6676507 ↗