VITEK® 2 AST-GN69Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03573026530921), received between Jan 5, 2018 and Nov 20, 2018 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (14 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, 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.

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-0833-2023 · Root cause: Storage · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED FALSE RESISTANT CARBAPENEM RESULTS FOR FOUR (4) STRAINS FROM PATIENT URINE SAMPLES, IN ASSOCIATION WITH THE VITEK® 2 AST-GN69 TEST KIT (LOT 5890803203). ON (B)(6) 2018, THE CUSTOMER STARTED OBTAINING RESISTANT RESULTS FOR MULTIPLE DRUGS ON THE AST-GN69 CARD FOR MULTIPLE PATIENTS. UPON REPEAT TESTING WITH KIRBY-BAUER, THE RESULTS WERE SUSCEPTIBLE. THE CUSTOMER REPORTED THAT THIS RESISTANCE PATTERN CONTINUED FOR DAYS WITH LOT 5890803203. ANOTHER LOT WAS THEN USED ON (B)(6) 2018 WITHOUT ISSUE. PATIENT STRAINS IMPACTED: (B)(6) - ESCHERICHIA COLI, (B)(6) - KLEBSIELLA PNEUMONIAE SSP PNEUMONIAE, (B)(6) - ESCHERICHIA COLI, (B)(6) - PROTEUS MIRABILIS. THE CUSTOMER REPORTED THAT AST-GN69 LOT 5890803203 ORIGINALLY PASSED QC ON (B)(6) 2018, BUT WEEKLY QC ON (B)(6) 2018 AND (B)(6) 2018 FAILED SEVERAL DRUGS. THE CUSTOMER STATED THEY DID NOT REPORT THE INCORRECT VITEK RESULTS, AS THEY REPEATED VITEK WITH KIRBY BAUER AND REPORTED THE CONSISTENT RESULTS. THE CUSTOMER STATED THERE WAS NO KNOWN IMPACT TO PATIENT TREATMENT. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8090339 ↗
• MalfunctionNov 20, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED FALSE RESISTANT CARBAPENEM RESULTS FOR FOUR (4) STRAINS FROM PATIENT URINE SAMPLES, IN ASSOCIATION WITH THE VITEK® 2 AST-GN69 TEST KIT (LOT 5890803203). ON (B)(6) 2018, THE CUSTOMER STARTED OBTAINING RESISTANT RESULTS FOR MULTIPLE DRUGS ON THE AST-GN69 CARD FOR MULTIPLE PATIENTS. UPON REPEAT TESTING WITH KIRBY-BAUER, THE RESULTS WERE SUSCEPTIBLE. THE CUSTOMER REPORTED THAT THIS RESISTANCE PATTERN CONTINUED FOR DAYS WITH LOT 5890803203. ANOTHER LOT WAS THEN USED ON (B)(6) 2018 WITHOUT ISSUE. PATIENT STRAINS IMPACTED: F71157 - ESCHERICHIA COLI; S54418 - KLEBSIELLA PNEUMONIAE SSP PNEUMONIAE; S56450 - ESCHERICHIA COLI; S56172 - PROTEUS MIRABILIS. THE CUSTOMER REPORTED THAT AST-GN69 LOT 5890803203 ORIGINALLY PASSED QC ON (B)(6) 2018, BUT WEEKLY QC ON (B)(6) 2018 FAILED SEVERAL DRUGS. THE CUSTOMER STATED THEY DID NOT REPORT THE INCORRECT VITEK RESULTS, AS THEY REPEATED VITEK WITH (B)(6) AND REPORTED THE CONSISTENT RESULTS. THE CUSTOMER STATED THERE WAS NO KNOWN IMPACT TO PATIENT TREATMENT. 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 PATIEN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8090333 ↗
• MalfunctionNov 20, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED FALSE RESISTANT CARBAPENEM RESULTS FOR FOUR (4) STRAINS FROM PATIENT URINE SAMPLES, IN ASSOCIATION WITH THE VITEK® 2 AST-GN69 TEST KIT (LOT 5890803203). ON (B)(6) 2018, THE CUSTOMER STARTED OBTAINING RESISTANT RESULTS FOR MULTIPLE DRUGS ON THE AST-GN69 CARD FOR MULTIPLE PATIENTS. UPON REPEAT TESTING WITH KIRBY-BAUER, THE RESULTS WERE SUSCEPTIBLE. THE CUSTOMER REPORTED THAT THIS RESISTANCE PATTERN CONTINUED FOR DAYS WITH LOT 5890803203. ANOTHER LOT WAS THEN USED ON (B)(6) 2018 WITHOUT ISSUE. PATIENT STRAINS IMPACTED: F71157 - ESCHERICHIA COLI; S54418 - KLEBSIELLA PNEUMONIAE SSP PNEUMONIAE; S56450 - ESCHERICHIA COLI; S56172 - PROTEUS MIRABILIS. THE CUSTOMER REPORTED THAT AST-GN69 LOT 5890803203 ORIGINALLY PASSED QC ON (B)(6) 2018, BUT WEEKLY QC ON (B)(6) 2018 FAILED SEVERAL DRUGS. THE CUSTOMER STATED THEY DID NOT REPORT THE INCORRECT VITEK RESULTS, AS THEY REPEATED VITEK WITH KIRBY BAUER AND REPORTED THE CONSISTENT RESULTS. THE CUSTOMER STATED THERE WAS NO KNOWN IMPACT TO PATIENT TREATMENT. 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 P

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8090329 ↗
• MalfunctionNov 20, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED FALSE RESISTANT CARBAPENEM RESULTS FOR FOUR (4) STRAINS FROM PATIENT URINE SAMPLES, IN ASSOCIATION WITH THE VITEK® 2 AST-GN69 TEST KIT (LOT 5890803203). ON (B)(6) 2018, THE CUSTOMER STARTED OBTAINING RESISTANT RESULTS FOR MULTIPLE DRUGS ON THE AST-GN69 CARD FOR MULTIPLE PATIENTS. UPON REPEAT TESTING WITH KIRBY-BAUER, THE RESULTS WERE SUSCEPTIBLE. THE CUSTOMER REPORTED THAT THIS RESISTANCE PATTERN CONTINUED FOR DAYS WITH LOT 5890803203. ANOTHER LOT WAS THEN USED ON (B)(6) 2018 WITHOUT ISSUE. PATIENT STRAINS IMPACTED: F71157 - ESCHERICHIA COLI. S54418 - KLEBSIELLA PNEUMONIAE SSP PNEUMONIAE. S56450 - ESCHERICHIA COLI. S56172 - PROTEUS MIRABILIS. THE CUSTOMER REPORTED THAT AST-GN69 LOT 5890803203 ORIGINALLY PASSED QC ON 21AUG18, BUT WEEKLY QC ON 08OCT2018 AND 15OCT2018 FAILED SEVERAL DRUGS. THE CUSTOMER STATED THEY DID NOT REPORT THE INCORRECT VITEK RESULTS, AS THEY REPEATED VITEK WITH KIRBY BAUER AND REPORTED THE CONSISTENT RESULTS. THE CUSTOMER STATED THERE WAS NO KNOWN IMPACT TO PATIENT TREATMENT. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8090326 ↗
• MalfunctionOct 30, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE RESISTANT TRIMETHOPRIM/SULFAMETHOXAZOLE (SXT) WHEN TESTING A PATIENT STRAIN OF STENOTROPHOMONAS MALTOPHILIA, ISOLATED FROM A URINE SAMPLE, WITH THE VITEK® 2 AST-GN69 TEST KIT (REF 413400). THE CUSTOMER REPEATED TESTING AND RECEIVED THE SAME FALSE RESISTANT RESULTS. THE CUSTOMER SENT OUT THE STRAIN TO A REFERENCE LAB, AND THEY OBTAINED A SUSCEPTIBLE RESULT. THE CUSTOMER REPORTED THAT THE PATIENT WAS ON ANTIBIOTICS: CIPRO 500MG. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8018955 ↗
• MalfunctionOct 2, 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 ALCALIGENES FAECALIS CAP SURVEY STRAIN IN ASSOCIATION WITH THE VITEK® 2 AST-GN69 TEST KIT. THE ALCALIGENES FAECALIS STRAIN TESTED RESISTANT (MIC >=128) AND THE EXPECTED RESULT WAS SUSCEPTIBLE. THE CUSTOMER REPEATED TESTING ON A DIFFERENT LOT AND THE RESULT WAS RESISTANT. THE CUSTOMER STATED THAT THEY OBTAINED A SUSCEPTIBLE RESULT WITH DISK DIFFUSION. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7925718 ↗
• MalfunctionOct 2, 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 ALCALIGENES FAECALIS (B)(4) STRAIN IN ASSOCIATION WITH THE VITEK® 2 AST-GN69 TEST KIT. THE ALCALIGENES FAECALIS STRAIN TESTED RESISTANT (MIC >=128) AND THE EXPECTED RESULT WAS SUSCEPTIBLE. THE CUSTOMER REPEATED TESTING ON A DIFFERENT LOT AND THE RESULT WAS RESISTANT. THE CUSTOMER STATED THAT THEY OBTAINED A SUSCEPTIBLE RESULT WITH DISK DIFFUSION. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7925707 ↗
• 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 A FALSE RESISTANT RESULT ASSOCIATED WITH VITEK® 2 AST-GN69 TEST KIT (REFERENCE (B)(4)). THE CUSTOMER REPORTED OBTAINING AN INCORRECT CAP SURVEY RESULT WHERE PIPERACILLIN/TAZOBACTAM WAS INCORRECT. THE EXPECTED RESULT WAS SENSITIVE. THE ORIGINAL RESULT WAS SUBMITTED AS RESISTANT >=128 (R). THE CUSTOMER PULLED THE SPECIMEN AND PERFORMED REPEAT TESTING ON VITEK® 2 AND MICROSCAN. VITEK® 2 YIELDED THE SAME RESULT OF >=128 (R) AND MICROSCAN HAD A RESULT OF <=16 (S). THE CUSTOMER MENTIONED THAT THIS PORTION OF THE SURVEY IS UNGRADED. THERE IS NO PATIENT INVOLVEMENT DUE TO BEING A CAP SURVEY. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7901319 ↗
• MalfunctionSep 20, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A FALSE RESISTANT RESULT ASSOCIATED WITH VITEK® 2 AST-GN69 TEST KIT (REFERENCE 413400). THE CUSTOMER REPORTED OBTAINING AN INCORRECT CAP SURVEY RESULT WHERE PIPERACILLIN/TAZOBACTAM WAS INCORRECT. THE EXPECTED RESULT WAS SENSITIVE. THE ORIGINAL RESULT WAS SUBMITTED AS RESISTANT >=128 (R). THE CUSTOMER PULLED THE SPECIMEN AND PERFORMED REPEAT TESTING ON VITEK® 2 AND MICROSCAN. VITEK® 2 YIELDED THE SAME RESULT OF >=128 (R) AND MICROSCAN HAD A RESULT OF <=16 (S). THE CUSTOMER MENTIONED THAT THIS PORTION OF THE SURVEY IS UNGRADED. THERE IS NO PATIENT INVOLVEMENT DUE TO BEING A CAP SURVEY. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7893101 ↗
• MalfunctionSep 19, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED FALSE RESISTANT PIPERACILIIN/TAZOBACTUM RESULTS FOR AN ALCALIGENES FAECALIS CAP SURVEY STRAIN (D-08), IN ASSOCIATION WITH THE VITEK® 2 AST-GN69 TEST KIT (LOT 5890692203). THE CUSTOMER TESTED THE STRAIN FROM BBL MACCONKEY MEDIA (VALIDATED) AND REPORTED THAT THE A. FAECALIS STRAIN WAS PIPERACILIIN/TAZOBACTUM RESISTANT (MIC >=128). THE EXPECTED CAP SURVEY RESULT WAS SUSCEPTIBLE. THE CUSTOMER THEN PERFORMED REPEAT TESTING WITH THE AST-N69 CARD AND THE RESULT WAS SUSCEPTIBLE (MIC <=4). TESTING WITH MICROSCAN GAVE A SUSCEPTIBLE RESULT (MIC<=16). A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7890679 ↗
• MalfunctionSep 10, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE SUSCEPTIBLE RESULTS FOR AN ESCHERICHIA COLI SURVEY STRAIN WHEN TESTING WITH THE VITEK® 2 AST-GN69 TEST KIT. THE CUSTOMER OBTAINED A SUSCEPTIBLE RESULT (MIC=8) FOR AMPICILLIN/SULBACTAM. THE EXPECTED RESULT FOR THIS SURVEY STRAIN IS RESISTANT. THE CUSTOMER WAS NOT ABLE TO REPEAT TESTING BECAUSE THEY NO LONGER HAD THE ISOLATE AVAILABLE. 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 7861873 ↗
• MalfunctionAug 29, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE SUSCEPTIBLE RESULTS FOR AN ESCHERICHIA COLI SURVEY STRAIN WHEN TESTING WITH THE VITEK® 2 AST-GN69 TEST KIT. THE CUSTOMER OBTAINED A SUSCEPTIBLE RESULT (MIC=8) FOR AMPICILLIN/SULBACTAM. THE EXPECTED RESULT FOR THIS SURVEY STRAIN IS RESISTANT. 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 7827713 ↗
• 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 AMPICILLIN/SULBACTAM RESULT FOR AN API SURVEY STRAIN (ESCHERICHIA COLI, ESBL) IN ASSOCIATION WITH THE VITEK® 2 AST-GN69 TEST KIT. THE EXPECTED RESULT WAS RESISTANT. THE CUSTOMER DID REPEAT THE TEST AND THE RESULT WAS THE SAME (SUSCEPTIBLE). A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7818424 ↗
• MalfunctionAug 22, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE SUSCEPTIBLE RESULTS FOR AN ESCHERICHIA COLI SURVEY STRAIN WHEN TESTING WITH THE VITEK® 2 AST-GN69 TEST KIT. THE CUSTOMER OBTAINED A SUSCEPTIBLE RESULT (MIC=8) FOR AMPICILLIN/SULBACTAM. THE EXPECTED RESULT FOR THIS SURVEY STRAIN IS INTERMEDIATE OR RESISTANT. THE CUSTOMER RETESTED THE STRAIN AND OBTAINED MIC=16 (INTERMEDIATE), WHICH IS ACCEPTABLE FOR THIS SURVEY. 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 7807114 ↗
• MalfunctionJan 5, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN THE UNITED STATES REPORTED THE OCCURRENCE OF FALSE RESISTANT ERTAPENEM RESULTS FOR CEPHALOSPORINS IN ASSOCIATION WITH THE VITEK® 2 AST-GN69 TEST KIT. ADVANCED EXPERT SYSTEM (AES) FOUND CRE (CARBAPENEM-RESISTANT ENTEROBACTERIACEAE) PHENOTYPES. TESTING VIA OFFLINE CRE TEST WAS NEGATIVE FOR CRE PHENOTYPE. THE CUSTOMER STATED THEY ARE USING TEST KITS ON THE AFFECTED LOT LIST ASSOCIATED WITH FIELD CORRECTIVE ACTION FSCA-3445 (VITEK 2 CARD POUCH INTEGRITY), AND STATED THE LABORATORY TECHNICIANS ARE LIKELY NOT INSPECTING THE CARD POUCHES PRIOR TO USE. THE CUSTOMER STATED RETESTING OBTAINED A MORE SUSCEPTIBLE RESULT. AMENDED REPORTS WERE SENT TO THE TREATING PHYSICIAN; DELAY >24 HOURS. THE CUSTOMER (MEDICAL DIRECTOR) PREFERRED TO NOT COMPLY WITH BIOMÉRIEUX'S REQUEST FOR LAB REPORTS; THEY STATED THEY BELIEVE THE ISSUE TO BE RESOLVED. IN ADDITION, THE SAMPLES WERE FROM URINARY TRACT INFECTIONS (UTI) SUCCESSFULLY TREATED WITH OTHER ANTIBIOTICS. THE CUSTOMER INDICATED THERE WAS NO ADVERSE IMPACT TO ANY PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL HAS BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167270 ↗

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