VITEK® 2 AST-ST01 VITEK®2 AST-ST01Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03573026529741), received between Aug 21, 2017 and Mar 7, 2018 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K111599, K111893, K111909, K111976, K112000, K112075, K112129, K112228, K113305, K121100, K121863, K122359); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF FALSE RESISTANT CEFTRIAXONE (MIC=1) FOR A STREPTOCOCCUS CONSTELLATUS ORGANISM IN ASSOCIATION WITH THE VITEK® 2 AST-ST03 CARD. REPEAT TESTING OBTAINED THE SAME RESULT. TESTING VIA ALTERNATE METHOD (ETEST® CEFTRIAXONE) PROVIDED A SUSCEPTIBLE RESULT (MIC=0.190). THE CUSTOMER STATED THE DISCREPANT VITEK® 2 AST-ST03 RESULT WAS NOT REPORTED TO THE TREATING PHYSICIAN AS THEY SYSTEMATICALLY PERFORM CONFIRMATORY TESTING FOR ANY CEFTRIAXONE RESISTANT RESULT; THEREFORE THERE WAS NO ADVERSE IMPACT TO THE PATIENT STATE OF HEALTH DUE TO THE VITEK® 2 AST-ST03 CEFTRIAXONE RESULT. HOWEVER, THERE WAS A DELAY IN REPORTING >24 HOURS DUE TO THE CONFIRMATORY TESTING VIA ETEST®. THOUGH THE VITEK® 2 AST-ST03 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES, CEFTRIAXONE IS REGISTERED WITH FDA AND IS INCLUDED IN VITEK® 2 AST-ST02 (REFERENCE (B)(4)) WHICH IS SOLD IN THE UNITED STATES. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7321561 ↗
• MalfunctionDec 28, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE RESISTANT CEFTRIAXONE RESULT WHEN PERFORMING SUSCEPTIBILITY TESTING WITH VITEK® 2 AST-ST01 TEST KIT (REF 410028), LOT 5400453103. VITEK® 2 OBTAINED A RESULT OF RESISTANT FOR A STREPTOCOCCUS ANGINOSUS ISOLATE OBTAINED FROM A DECUBITUS SAMPLE FROM A (B)(6) PATIENT. ETEST WAS PERFORMED TO CONFIRM THE RESULT AND PROVIDED A RESULT OF SUSCEPTIBLE (MIC 0.064). 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. THE CUSTOMER STATED THERE WAS A DELAY OF GREATER THAN 24 HOURS IN REPORTING THE PATIENT RESULTS. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7153226 ↗
• MalfunctionDec 28, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE RESISTANT CEFTRIAXONE RESULT WHEN PERFORMING SUSCEPTIBILITY TESTING WITH VITEK® 2 AST-ST01 TEST KIT (REF 410028), LOT 5400472203. VITEK® 2 OBTAINED A RESULT OF RESISTANT FOR A STREPTOCOCCUS ANGINOSUS ISOLATE OBTAINED FROM A SUBMANDIBULAR ABSCESS ON A (B)(6) PATIENT. ETEST WAS PERFORMED TO CONFIRM THE RESULT AND PROVIDED A RESULT OF SUSCEPTIBLE (MIC 0.25). 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. THE CUSTOMER STATED THERE WAS A DELAY OF GREATER THAN 24 HOURS IN REPORTING THE PATIENT RESULTS. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7153224 ↗
• MalfunctionDec 28, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE RESISTANT CEFTRIAXONE RESULT WHEN PERFORMING SUSCEPTIBILITY TESTING WITH VITEK® 2 AST-ST01 TEST KIT (REF 410028), LOT 5400453103. VITEK® 2 OBTAINED A RESULT OF RESISTANT FOR A STREPTOCOCCUS ANGINOSUS ISOLATE OBTAINED FROM A RETROPHARYNGEAL ABSCESS FROM AN (B)(6) PATIENT. BESTBION MIC TEST STRIPS WERE USED TO CONFIRM THE RESULT AND PROVIDED A RESULT OF SUSCEPTIBLE (MIC 0.064). 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. THE CUSTOMER STATED THERE WAS A DELAY OF GREATER THAN 24 HOURS IN REPORTING THE PATIENT RESULTS. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7153171 ↗
• MalfunctionDec 15, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE RESISTANT CEFTRIAXONE RESULTS WHEN PERFORMING SUSCEPTIBILITY TESTING WITH VITEK® 2 AST-ST01 TEST KIT (REF 410028). VITEK® 2 OBTAINED A RESULT OF CEFTRIAXONE RESISTANT FOR STREPTOCOCCUS CONSTELLATUS. ETEST® WAS PERFORMED TO CONFIRM THE RESULT, AND IT PROVIDED A RESULT OF SUSCEPTIBLE (MIC 0.19). 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. THE CUSTOMER STATED THERE WAS A DELAY IN REPORTING PATIENT RESULTS OF GREATER THAN 24 HOURS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7122254 ↗
• MalfunctionDec 15, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE RESISTANT CEFTRIAXONE RESULTS WHEN PERFORMING SUSCEPTIBILITY TESTING WITH VITEK® 2 AST-ST01 TEST KIT (REF 410028). VITEK® 2 OBTAINED A RESULT OF CEFTRIAXONE RESISTANT FOR STREPTOCOCCUS CONSTELLATUS. ETEST® WAS PERFORMED TO CONFIRM THE RESULT, AND IT PROVIDED A RESULT OF SUSCEPTIBLE (MIC 0.19). 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. THE CUSTOMER STATED THERE WAS A DELAY IN REPORTING PATIENT RESULTS OF GREATER THAN 24 HOURS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7122248 ↗
• MalfunctionDec 12, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE RESISTANT PENICILLIN RESULT WHEN PERFORMING SUSCEPTIBILITY TESTING WITH VITEK® 2 AST-ST01 TEST KIT (REF 410028), LOT 5400453103. VITEK® 2 OBTAINED A RESULT OF RESISTANT (MIC 0.12) FOR STREPTOCOCCUS PNEUMONIAE. ETEST® WAS PERFORMED TO CONFIRM THE RESULT, AND IT PROVIDED A RESULT OF SUSCEPTIBLE (MIC 0.023). 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. THE CUSTOMER STATED THERE WAS A DELAY IN REPORTING PATIENT RESULTS OF GREATER THAN 24 HOURS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7110097 ↗
• MalfunctionDec 7, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF FALSE RESISTANT PENICILLIN RESULTS WHEN PERFORMING SUSCEPTIBILITY TESTING WITH VITEK 2 AST-ST01 TEST KIT (REF (B)(4). VITEK 2 OBTAINED A RESULT OF RESISTANT (MIC 0.12) FOR STREPTOCOCCUS PNEUMONIAE. ETEST WAS PERFORMED TO CONFIRM THE RESULT, AND IT PROVIDED A RESULT OF SUSCEPTIBLE (MIC 0.023). 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. THE CUSTOMER STATED THERE WAS A DELAY IN REPORTING PATIENT RESULTS OF GREATER THAN 24 HOURS. A BIOMERIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7095391 ↗
• MalfunctionDec 7, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE RESISTANT CEFTRIAXONE RESULTS WHEN PERFORMING SUSCEPTIBILITY TESTING WITH VITEK® 2 AST-ST01 TEST KIT (REF 410028). VITEK® 2 OBTAINED A RESULT OF RESISTANT FOR STREPTOCOCCUS CONSTELLATUS. ETEST® WAS PERFORMED TO CONFIRM THE RESULT, AND IT PROVIDED A RESULT OF SUSCEPTIBLE (MIC 0.19). 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. THE CUSTOMER STATED THERE WAS A DELAY IN REPORTING PATIENT RESULTS OF GREATER THAN 24 HOURS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7095385 ↗
• MalfunctionNov 21, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE RESISTANCE FOR CEFTRIAXONE WHEN PERFORMING SUSCEPTIBILITY TESTING WITH VITEK® 2 AST-ST01 TEST KIT (REF 410028). VITEK® 2 OBTAINED A RESULT OF RESISTANT FOR A STAPHYLOCOCCUS CONSTELLATUS STRAIN ISOLATED FROM A CEREBRAL ABSCESS FROM A (B)(6) PATIENT. ETEST® WAS PERFORMED TO CONFIRM THE RESULT, AND IT PROVIDED A RESULT OF SUSCEPTIBLE (MIC 0.19). THE CUSTOMER STATED THAT THERE WERE NO WRONG RESULTS REPORTED TO A PHYSICIAN. 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. THE CUSTOMER STATED THERE WAS A DELAY IN REPORTING PATIENT RESULTS OF GREATER THAN 24 HOURS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7048335 ↗
• MalfunctionAug 21, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT FALSE RESISTANT CEFTRIAXONE (MIC = 1) FOR STREPTOCOCCUS CONSTELLATUS IN ASSOCIATION WITH THE VITEK® 2 AST-ST01 TEST KIT. ETEST® OBTAINS A RESULT OF MIC = 0.25 OR 0.19 (SUSCEPTIBLE). THE CUSTOMER STATED THAT ONLY THE ETEST® RESULT WAS REPORTED TO THE PHYSICIAN. THE DISCREPANT VITEK® 2 AST-ST01 RESULT HAD NO IMPACT ON PATIENT TREATMENT AND NO ADVERSE IMPACT ON THE PATIENT'S STATE OF HEALTH. THE CUSTOMER INDICATED A DELAY OF >24 HOURS TO REPORT THE ETEST® RESULT TO THE PHYSICIAN. BIOMÉRIEUX HAS REQUESTED ISOLATE SUBMITTAL FOR INTERNAL INVESTIGATION. AN INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6807101 ↗
• MalfunctionAug 21, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT FALSE RESISTANT CEFOTAXIME FOR STREPTOCOCCUS CONSTELLATUS IN ASSOCIATION WITH THE VITEK® 2 AST-ST01 TEST KIT. ETEST® OBTAINS A RESULT OF SUSCEPTIBLE. THE CUSTOMER STATED THAT ONLY THE ETEST® RESULT WAS REPORTED TO THE PHYSICIAN. THE DISCREPANT VITEK® 2 AST-ST01 RESULT HAD NO IMPACT ON PATIENT TREATMENT AND NO ADVERSE IMPACT ON THE PATIENT'S STATE OF HEALTH. THE CUSTOMER INDICATED A DELAY OF >24 HOURS TO REPORT THE ETEST® RESULT TO THE PHYSICIAN. BIOMÉRIEUX HAS REQUESTED ISOLATE SUBMITTAL FOR INTERNAL INVESTIGATION. AN INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6807096 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111599, K111893, K111909, K111976, K112000, K112075, K112129, K112228, K113305, K121100, K121863, K122359. One submission often covers many models, so check the product and lot details in each record.

• Z-0848-2023 · Nov 9, 2022 · Open, Classified
  VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915