VITEK® 2 AST-GP67Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 03573026530648), received between Jun 29, 2017 and Dec 2, 2020 — classified as 83 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (65 reports).

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

2 other recalls cover devices cleared under the same FDA submission (K032399, K032738, K032766, K050976, K053097, K072668, K072695, K080201, 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-0792-2023 · Root cause: Storage · Recall details · FDA record ↗

2. Jan 26, 2018Terminated

   Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.

   Z-2817-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOM¿RIEUX OF OBTAINING A FALSE POSITIVE RESULT FOR CEFOXITIN SCREEN WHILE TESTING A (B)(6) ATCC¿ 29213" QC STRAIN USING THE VITEK¿ 2 AST-GP67 TEST KIT (REFERENCE #: (B)(4), LOT #: 1321529403). THE CUSTOMER STATED THEY DO NOT REPEAT VITEK 2 RESULTS IF THEY GET A FALSE POSITIVE CEFOXITIN SCREEN. INSTEAD THEY CONFIRM RESULTS USING PCR AS AN ALTERNATIVE TESTING METHOD. A FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE ON 15NOV2020, AND REPLACED THE B SIDE OPTICS. THE CUSTOMER HAS HAD NO ISSUES SINCE THE OPTICS WERE REPLACED. SINCE THE CUSTOMER IS NO LONGER HAVING ISSUES THEY HAVE DECLINED TO PROVIDE FURTHER INFORMATION AT THIS TIME DUE TO TIME-CONSTRAINTS. THERE IS NO PATIENT ASSOCIATED WITH THIS QC ISOLATE; THEREFORE, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOM¿RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 10932707 ↗
• MalfunctionDec 2, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE RESULT FOR CEFOXITIN SCREEN WHILE TESTING (B)(6) PATIENT STRAINS USING THE VITEK® 2 AST-GP67 TEST KIT (REFERENCE # 22226, LOT # 1321529403). THE CUSTOMER DID NOT PROVIDE THE NUMBER OF PATIENT STRAINS IMPACTED. THE CUSTOMER STATED THEY DO NOT REPEAT VITEK 2 RESULTS IF THEY GET A FALSE POSITIVE CEFOXITIN SCREEN. INSTEAD THEY CONFIRM RESULTS USING PCR AS AN ALTERNATIVE TESTING METHOD. A FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE ON (B)(6) 2020 AND REPLACED THE B SIDE OPTICS. THE CUSTOMER HAS HAD NO ISSUES SINCE THE OPTICS WERE REPLACED. SINCE THE CUSTOMER IS NO LONGER HAVING ISSUES THEY HAVE DECLINED TO PROVIDE FURTHER INFORMATION AT THIS TIME DUE TO TIME-CONSTRAINTS. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10932693 ↗
• MalfunctionOct 7, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE RESISTANT OXACILLIN (OX) RESULT FOR A STAPHYLOCOCCUS AUREUS PATIENT ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF. 22226, LOT 1321426103). AN OXACILLIN MIC >=4 IS RESISTANT. THIS IN TURN CAUSED THE ADVANCED EXPERT SYSTEM¿ (AES) TO PROPOSE THE PLP MECA PHENOTYPE AND MODIFIED THE CEFOXITIN SCREEN RESULT FROM NEG (-) TO POS (+) AND PENICILLIN FROM SUSCEPTIBLE TO RESISTANT. THE CUSTOMER PERFORMED CONFIRMATORY TESTING WITH GP, COAGULASE, OXASCREEN (AGAR), AND MRSA RAPID; DETERMINED THE STAPHYLOCOCCUS AUREUS STRAIN WAS SUSCEPTIBLE TO OXACILLIN. THERE WAS A PRELIMINARY REPORT OF SARO RELEASED FOR THE PATIENT. A CORRECTED REPORT WAS PROVIDED TO THE PHYSICIAN. POTENTIAL REASONS FOR FALSE RESISTANCE INCLUDE: AN INOCULUM THAT IS TOO DENSE. THE AGE OF THE ORGANISM IS TOO YOUNG WHEN INOCULATED INTO THE CARD. THE USE OF NON-RECOMMENDED MEDIA. LOW LEVEL SALINE CONTAMINATION. USE OF A MIXED CULTURE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10643488 ↗
• MalfunctionSep 23, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE RESISTANT OXACILLIN RESULT IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF. 22226 LOT, 1321480203) WHEN TESTING A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE. THE CUSTOMER STATED LOT 1321480203 OBTAINED AN OXACILLIN MIC >=4 RESISTANT. THIS RESISTANT RESULT THEN CAUSED THE NEGATIVE CEFOXITIN SCREEN RESULT TO BE MODIFIED TO POSITIVE BY THE VITEK® 2 ADVANCED EXPERT SYSTEM¿ (AES). THE ISOLATE WAS TESTED TWICE USING VITEK® 2 AST-GP78 TEST KIT (REF. 421051, LOT 2781427403); BOTH TESTS OBTAINED AN OXACILLIN MIC >=4 RESISTANT. REFER TO CN-091435. THE CUSTOMER ALSO TESTED THE STAPHYLOCOCCUS AUREUS ISOLATE USING THE OXPLATE, PCR, AND PBP2A TEST METHODS. ALL ALTERNATIVE TEST METHODS OBTAINED A NEGATIVE (SUSCEPTIBLE) RESULT. 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. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10572868 ↗
• MalfunctionAug 24, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A (B)(6) RESISTANT OXACILLIN RESULT FOR (B)(6) WHILE TESTING A PATIENT URINE SAMPLE USING THE VITEK® 2 AST-GP67 TEST KIT (REFERENCE # 22226, LOT # 1321295403). INITIAL VITEK® 2: OXACILLIN MIC >= 4, (RESISTANT). REPEAT VITEK® 2: OXACILLIN MIC >= 4, (RESISTANT). ALTERNATE METHOD RESULTS: (B)(6) RAPIDE AND OXASCREEN: (B)(6) (SUSCEPTIBLE) IDENTIFICATION CONFIRMED AS (B)(6). THE OXACILLIN SUSCEPTIBLE RESULTS FROM THE MANUAL METHODS WERE REPORTED TO THE PHYSICIAN; THEREFORE, NO WRONG RESULTS WERE REPORTED. THE CUSTOMER STATED THAT THERE WAS A DELAY OF >24 HOURS IN REPORTING THE RESULT, BUT THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE FALSE RESISTANT 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 10441616 ↗
• MalfunctionJul 29, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE (B)(6) CEFOXITIN SCREEN RESULTS FOR A PATIENT (B)(6) ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF (B)(4), LOT 1321384203). THE (B)(6) CEFOXITIN SCREEN RESULTS ARE OBTAINED ON ONE INSTRUMENT, BUT THE CUSTOMER'S OTHER INSTRUMENT OBTAINS (B)(6) RESULTS. KIRBY BAUER DISK DIFFUSION TESTING WAS PERFORMED AS AN ALTERNATIVE METHOD AND OBTAINED (B)(6) (SUSCEPTIBLE) RESULTS. REPEAT ANALYSIS WITH THE VITEK® 2 AST-GP67 TEST KIT WAS PERFORMED ON TWO DIFFERENT INSTRUMENTS. THE INSTRUMENT USED FOR INITIAL TESTING OBTAINED THE SAME (B)(6) RESULT WHEN REPEAT ANALYSIS WAS PERFORMED. THE OTHER INSTRUMENT OBTAINED THE EXPECTED (B)(6) (SUSCEPTIBLE) RESULT. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THE (B)(6) CEFOXITIN SCREEN RESULTS 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 10339584 ↗
• MalfunctionJun 25, 2020False Positive Result; False Positive Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF A FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN RESULT FOR A STAPHYLOCOCCUS AUREUS QC STRAIN IN ASSOCIATION WITH VITEK® 2 AST-GP67 TEST KIT (REF. 22226, LOT 1321166403). THE INITIAL TEST GAVE A RESULT OF CEFOXITIN SCREEN POSITIVE. THE EXPECTED RESULT WAS NEGATIVE. MULTIPLE REPEAT TESTS WERE PERFORMED ON THE STRAIN, AND THE RESULTS WERE ALL NEGATIVE. THE FALSE POSITIVE RESULT WAS NOT REPRODUCED. 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 BIOMERIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 10196585 ↗
• MalfunctionJun 25, 2020False Positive Result; False Positive Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF A FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN RESULT FOR A STAPHYLOCOCCUS AUREUS QC STRAIN IN ASSOCIATION WITH VITEK® 2 AST-GP67 TEST KIT (REF. 22226, LOT 1321335203). THE INITIAL TEST PROVIDED A RESULT OF CEFOXITIN SCREEN POSITIVE. THE EXPECTED RESULT WAS NEGATIVE. A REPEAT TEST WAS PERFORMED, AND THE RESULT WAS NEGATIVE. 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 BIOMERIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 10196576 ↗
• MalfunctionMar 26, 2020False Negative Result; False Negative Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE CEFOXITIN SCREEN (OXSF) RESULT FOR STAPHYLOCOCCUS AUREUS IN CONJUNCTION WITH THE VITEK 2 AST-GP67 TEST KIT (REF. 22226, LOT 1321260213). IN ADDITION, THE ASSOCIATED OXACILLIN RESULT WAS FALSE SUSCEPTIBLE (MIC <=0.25). REPEAT TEST OBTAINED THE SAME RESULTS. ALTERNATE METHOD TESTING VIA PBP2A AND BIOFIRE BCID PROVIDED RESULTS OF "POSITIVE". 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9883386 ↗
• MalfunctionMar 26, 2020False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE CEFOXITIN SCREEN RESULT FOR STAPHYLOCOCCUS AUREUS WHILE TESTING A PATIENT ISOLATE USING THE VITEK® 2 AST-GP67 TEST KIT (REFERENCE #22226, LOT # 1321260213). AST-GP67 RESULTS: CEFOXITIN SCREEN: POSITIVE. OXACILLIN: MIC = 0.5. ALTERNATE METHOD RESULTS: PBP2A: NEGATIVE. NO REPEAT TESTING WAS PERFORMED. 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 9882339 ↗
• MalfunctionMar 20, 2020False Negative Result; False Negative Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE SUSCEPTIBLE CEFOXITIN SCREEN FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF 22226, LOT 1321239413). THE CUSTOMER STATED THAT SEVERAL STAPHYLOCOCCUS AUREUS ISOLATES FROM THE SAME PATIENT WERE COLLECTED FROM DIFFERENT SITES (BLOOD AND URINE) AND TESTED WITH THE VITEK® 2 AST-GP67 TEST KIT (REF 22226, LOT 1321239413). INITIAL AND REPEAT ANALYSIS WITH THE VITEK® 2 AST-GP67 TEST KIT OBTAINED SUSCEPTIBLE CEFOXITIN SCREEN RESULTS. (B)(6) TESTING WAS PERFORMED AS AN ALTERNATE METHOD AND OBTAINED POSITIVE (RESISTANT) RESULTS. INITIAL VITEK® 2: OXACILLIN MIC <= 0.25 MG/L (SUSCEPTIBLE), CEFOXITIN SCREEN: NEGATIVE (SUSCEPTIBLE), REPEAT VITEK® 2: OXACILLIN MIC <= 0.25 MG/L (SUSCEPTIBLE), CEFOXITIN SCREEN: NEGATIVE (SUSCEPTIBLE), ALTERNATE METHOD RESULTS: (B)(6): POSITIVE (RESISTANT). (B)(6) WAS INITIALLY REPORTED TO THE PHYSICIAN, THEN CORRECTED TO (B)(6) AFTER THE PHYSICIAN QUESTIONED THE RESULTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THIS EVENT 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 9861135 ↗
• MalfunctionMar 11, 2020False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED SATES NOTIFIED BIOMÉRIEUX OF A FALSE POSITIVE CEFOXITIN SCREEN RESULT FOR A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF. 22226, LOT 1321260213). THE ISOLATE OBTAINED A POSITIVE CEFOXITIN SCREEN RESULT WITH A SUSCEPTIBLE OXACILLIN RESULT THAT WAS MODIFIED TO RESISTANT BY THE ADVANCED EXPERT SYSTEM (AES). THE ISOLATE WAS RETESTED ON THE VITEK® 2 AND USING THE MECA TEST METHOD; BOTH ASSAYS OBTAINED A NEGATIVE RESULT. THE CUSTOMER CONFIRMED THE POSITIVE CEFOXITIN SCREEN RESULT WAS REPORTED TO THE TREATING PHYSICIAN. HOWEVER, THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM OR INCORRECT TREATMENT DUE TO THE DISCREPANT RESULT. NOTE: CUSTOMER REPORT HAD A COMMENT ENABLED STATING ¿IF CEFOXITIN SCREEN IS POSITIVE AND OXACILLIN RESULT IS SUSCEPTIBLE: RECHECK ID AND CONFIRM PURITY ¿ REPEAT TESTING ¿ IF STILL INCONSISTENT, CONFIRM WITH MECA TEST BEFORE REPORTING.¿ BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9820672 ↗
• MalfunctionFeb 26, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF 22226, LOT 1321166403). REPEAT ANALYSIS WITH THE VITEK® 2 AST-GP67 TEST KIT OBTAINED A NEGATIVE (SUSCEPTIBLE) OXSF RESULT. OXASCREEN TESTING WAS PERFORMED AS AN ALTERNATIVE METHOD AND OBTAINED SUSCEPTIBLE RESULTS. INITIAL VITEK® 2: OXSF = POSITIVE (RESISTANT). REPEAT VITEK® 2: OXSF = NEGATIVE (SUSCEPTIBLE). OXASCREEN = SUSCEPTIBLE. THE CUSTOMER INDICATED THAT THERE WAS A DELAY OF >24 HOURS IN REPORTING RESULTS, BUT THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THE INITIAL FALSE POSITIVE CEFOXITIN SCREEN 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 9756091 ↗
• MalfunctionJan 28, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE CEFOXITIN SCREEN RESULTS FOR A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF 22226, LOT 1321144103). REPEAT ANALYSIS WITH THE VITEK® 2 AST-GP67 TEST KIT OBTAINED NEGATIVE RESULTS. INITIAL VITEK® 2: CEFOXITIN SCREEN = POSITIVE (RESISTANT). REPEAT VITEK® 2: CEFOXITIN SCREEN = NEGATIVE (SUSCEPTIBLE). THE CUSTOMER STATED THAT THERE WAS A DELAY OF >24 HOURS IN REPORTING THE RESULT, BUT THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE INITIAL FALSE POSITIVE 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 9638711 ↗
• MalfunctionJan 24, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE RESISTANT OXACILLIN RESULTS FOR A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF 22226, LOT 1321144103). REPEAT ANALYSIS WITH THE VITEK® 2 AST-GP67 TEST KIT OBTAINED A SUSCEPTIBLE RESULT. INITIAL VITEK® 2: OXACILLIN MIC >= 4 MG/L (RESISTANT). REPEAT VITEK® 2: OXACILLIN MIC = 0.5 MG/L (SUSCEPTIBLE). THE CUSTOMER CONFIRMED THAT THERE WAS A DELAY OF > 24 HOURS IN REPORTING RESULTS DUE TO THE REPEAT TESTING. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE FALSE RESISTANT RESULT OR DELAY LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9629864 ↗
• MalfunctionJan 16, 2020False Positive Result; False Positive Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF A FALSE POSITIVE CEFOXITIN SCREEN FOR A PATIENT STAPHYLOCOCCUS AUREUS STRAIN IN ASSOCIATION WITH THE VITEK® AST-GP67 TEST KIT (REF# 22226, LOT# 1321039203). SOFTWARE VERSION (B)(4). THE CUSTOMER IDENTIFIED THE STRAIN AS STAPHYLOCOCCUS AUREUS USING THE VITEK® MS. INITIAL TEST RESULTS: AST-GP67. LOT 1321039203. CEFOXITIN SCREEN (OXSF) = POSITIVE. OXACILLIN (OX1) - MIC = 0.5, CHANGED TO RESISTANT. EXPECTED RESULTS: CEFOXITIN SCREEN (OXSF) = NEGATIVE. OXACILLIN (OX1) = SUSCEPTIBLE. ALTERNATE TEST RESULTS: DISK DIFFUSION: CEFOXITIN = SUSCEPTIBLE. OXACILLIN = SUSCEPTIBLE. PCR FILMARRAY PNEUMONIA PLUS PANEL MECA/C MECJ NOT DETECTED. RESULT: FILMARRAY SA DETECTED BUT NOT RESISTANCE GENES. REPEAT TESTING RESULTS: AST-GP67. LOT 1321039203. CEFOXITIN SCREEN (OXSF) = NEGATIVE. 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 9598354 ↗
• MalfunctionJan 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE RESISTANT OXACILLIN RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF 22226, LOT 1321144103). VITEK® 2: OXACILLIN MIC >= 4 MG/L (RESISTANT). EXPECTED: OXACILLIN = SUSCEPTIBLE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE FALSE RESISTANT 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 9585998 ↗
• MalfunctionJan 2, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE RESISTANT OXACILLIN RESULTS FOR A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 (REF 22226, LOT 1321130103). OXASCREEN AND RAPID (B)(6) TESTING WERE PERFORMED AS ALTERNATIVE METHODS. VITEK® 2: OXACILLIN = RESISTANT. OXASCREEN: OXACILLIN = SUSCEPTIBLE. RAPID MRSA: NEGATIVE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE FALSE RESISTANT 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 9538540 ↗
• MalfunctionDec 5, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE CEFOXITIN SCREEN RESULTS FOR A STAPHYLOCOCCUS AUREUS ATCC® 29213¿ ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF 22226, LOT 1320596203). THE STRAIN WAS TESTED BY MICROBIOLOGICS, INC WITH ANOTHER LOT OF THE VITEK® 2 AST-GP67 TEST KIT AND OBTAINED THE EXPECTED NEGATIVE CEFOXITIN SCREEN RESULT. AS THIS WAS A QC STRAIN, THERE WAS NO PATIENT INVOLVED. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 9417527 ↗
• MalfunctionDec 5, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE CEFOXITIN SCREEN RESULTS FOR A STAPHYLOCOCCUS AUREUS ATCC® 29213¿ ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF 22226, LOT 1321211203). THE STRAIN WAS TESTED BY (B)(6) WITH ANOTHER LOT OF THE VITEK® 2 AST-GP67 TEST KIT AND OBTAINED THE EXPECTED NEGATIVE CEFOXITIN SCREEN RESULT. AS THIS WAS A QC STRAIN, THERE WAS NO PATIENT INVOLVED. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 9416225 ↗
• MalfunctionNov 15, 2019False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE CEFOXITIN SCREEN WHEN TESTING A STAPHYLOCOCCUS AUREUS PATIENT ISOLATE WITH THE VITEK® 2 AST-GP67 TEST KIT (REFERENCE # 22226, LOT # 1321130103). THE CUSTOMER WAS TRYING TO VALIDATE THE AST-GP75 CARD AND RECEIVED CONFLICTING RESULTS. AST-GP67 CARD: OXACILLIN MIC = 2 SUSCEPTIBLE, CEFOXITIN SCREEN = POSITIVE, SET UP FROM ORIGINAL CULTURE. AST-GP75 CARD: OXACILLIN MIC <= 0.25, CEFOXITIN SCREEN = NEGATIVE, SET UP FROM PURITY PLATE. REPEAT TESTING OF THE AST-GP67 CARD: OXACILLIN MIC = 2 SUSCEPTIBLE, CEFOXITIN SCREEN = NEGATIVE. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9328146 ↗
• MalfunctionOct 30, 2019Incorrect, 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 OXACILLIN RESULT FOR A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF 22226, LOT 1321158103). INITIAL TESTING COMPLETED WITH 1321079103 OBTAINED RESISTANT OXACILLIN RESULTS. ALTERNATE TESTING RESULTS SHOWED THAT THE ISOLATE WAS PBP2A NEGATIVE AND MECA NEGATIVE. DISK DIFFUSION TESTING OBTAINED (B)(6) RESULTS. THE STRAIN WAS SENT TO A REFERENCE LABORATORY AND CONFIRMED TO BE (B)(6). VITEK® 2 AST-GP67 TEST KIT (REF 22226, LOT 1321158103) WAS USED FOR REPEAT ANALYSIS AFTER RECEIVING RESULTS FROM THE REFERENCE LABORATORY AND OBTAINED RESISTANT OXACILLIN RESULTS. THE CUSTOMER REPORTED THAT THE PATIENT WAS TREATED WITH VANCOMYCIN DUE TO THE INITIAL RESISTANT OX RESULT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT AND TREATMENT WITH VANCOMYCIN 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 9257140 ↗
• MalfunctionOct 18, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE CEFOXITIN SCREEN (OXFS) RESULT FOR STAPHYLOCOCCUS AUREUS (S. AUREUS) ATCC® 29219¿ WHILE USING THE VITEK® 2 AST-GP67 TEST KIT (REF. 22226, LOT 1321079103) WITH SOFTWARE VERSION 8.01. THE CUSTOMER REPEATED TESTING ON THE VITEK 2 WHICH YIELDED A POSITIVE OXFS RESULT. THE CUSTOMER STATED THE EXPECTED RESULT FOR S. AUREUS ATCC 29219 WAS OXFS NEGATIVE. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 9207789 ↗
• MalfunctionOct 10, 2019Incorrect, 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 OXACILLIN RESULT FOR A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF 22226, LOT 1321079103). INITIAL AND REPEAT ANALYSIS OBTAINED RESISTANT OXACILLIN (OX) RESULTS AND CEFOXITIN SCREEN (OXSF) NEGATIVE RESULTS. ALTERNATE TESTING RESULTS SHOWED THAT THE ISOLATE WAS PBP2A NEGATIVE AND MECA NEGATIVE. DISK DIFFUSION TESTING OBTAINED SUSCEPTIBLE OXACILLIN RESULTS. THE STRAIN WAS SENT TO A REFERENCE LABORATORY AND CONFIRMED TO BE OXACILLIN SUSCEPTIBLE. THE CUSTOMER REPORTED THAT THE PATIENT WAS TREATED WITH VANCOMYCIN DUE TO THE INITIAL RESISTANT OX RESULT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT AND TREATMENT WITH VANCOMYCIN 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 9175803 ↗
• MalfunctionOct 7, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE RESISTANT (B)(6) RESULTS WHEN TESTING TWO (B)(6) ISOLATES FROM SEPARATE PATIENTS (ONE FROM BLOOD AND THE OTHER FROM URINE) USING THE VITEK® 2 AST-GP67 TEST KIT (REFERENCE 22226, LOT# 1321110103) WITH SOFTWARE VERSION 8.01. THE CUSTOMER STATED THE BLOOD ISOLATE TESTED NEGATIVE FOR CEFOXITIN SCREEN, BUT WAS MODIFIED TO RESISTANT DUE TO A (B)(6) MINIMUM INHIBITORY CONCENTRATION (MIC) OF FOUR. THE ISOLATE WAS ALSO TESTED USING PBP2A, VERIGENE® MECA, AND CEFOXITIN DISC DIFFUSION, ALL ASSAYS YIELDED NEGATIVE (SUSCEPTIBLE) RESULTS. BIOMÉRIEUX HAS REQUESTED FURTHER INFORMATION REGARDING THE URINE ISOLATE. 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. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9163988 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032399, K032738, K032766, K050976, K053097, K072668, K072695, K080201, N50510. One submission often covers many models, so check the product and lot details in each record.

• Z-0843-2023 · Nov 9, 2022 · Open, Classified
  VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670
• Z-1742-2020 · Mar 11, 2020 · Open, Classified
  The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcu