VITEK® 2 AST-GP75Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 03573026530679), received between May 9, 2017 and Jan 6, 2021 — classified as 1 injury, 51 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (23 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, K032766, K050976, K053097, K072668, K072695, K080201, K091126, K093076, K122547, 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-0843-2023 · Root cause: Storage · 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2021False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOM¿RIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN RESULTS FOR STAPHYLOCOCCUS AUREUS FOR SIX (6) DIFFERENT PATIENTS IN ASSOCIATION WITH THE VITEK¿ 2 AST-GP75 TEST KIT (REF 415670, LOT 2751438113). THE CUSTOMER STATED THAT CEFOXITIN SCREEN RESULTS WERE POSITIVE WHILE THE OXACILLIN RESULTS WERE SUSCEPTIBLE (MIC<=0.25 OR =0.5), BUT AES (ADVANCED EXPERT SYSTEM") CORRECTED THE INTERPRETATION FOR OXACILLIN TO RESISTANT BASED ON THE POSITIVE CEFOXITIN SCREEN RESULTS. THE CUSTOMER DOES NOT PERFORM ANY ALTERNATIVE METHOD FOR CEFOXITIN SCREEN, BUT DISK DIFFUSION TESTING FOR OXACILLIN WAS PERFORMED AND OBTAINED SUSCEPTIBLE RESULTS. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE AND CLEANED THE INSTRUMENT'S OPTICS AND CHECKED THE ALIGNMENT. THE CUSTOMER REPORTED THAT THEY HAVE NOT OBTAINED ANY DISCREPANT CEFOXITIN SCREEN RESULTS SINCE THE OPTICS CLEANING AND ALIGNMENT. RETEST OF THREE (3) OF THE ORIGINAL SIX (6) ISOLATES OBTAINED THE EXPECTED RESULTS. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMERIEUX INVESTIGATION HAS BEEN INITIA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11123945 ↗
• MalfunctionJan 6, 2021False Positive Result; False Positive Result

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOM¿RIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN RESULTS FOR STAPHYLOCOCCUS AUREUS FOR SIX (6) DIFFERENT PATIENTS IN ASSOCIATION WITH THE VITEK¿ 2 AST-GP75 TEST KIT REF 415670, LOT 2751438113. THE CUSTOMER STATED THAT CEFOXITIN SCREEN RESULTS WERE POSITIVE WHILE THE OXACILLIN RESULTS WERE SUSCEPTIBLE (MIC<=0.25 OR =0.5), BUT AES (ADVANCED EXPERT SYSTEM") CORRECTED THE INTERPRETATION FOR OXACILLIN TO RESISTANT BASED ON THE POSITIVE CEFOXITIN SCREEN RESULTS. THE CUSTOMER DOES NOT PERFORM ANY ALTERNATIVE METHOD FOR CEFOXITIN SCREEN, BUT DISK DIFFUSION TESTING FOR OXACILLIN WAS PERFORMED AND OBTAINED SUSCEPTIBLE RESULTS. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE AND CLEANED THE INSTRUMENT'S OPTICS AND CHECKED THE ALIGNMENT. THE CUSTOMER REPORTED THAT THEY HAVE NOT OBTAINED ANY DISCREPANT CEFOXITIN SCREEN RESULTS SINCE THE OPTICS CLEANING AND ALIGNMENT. RETEST OF THREE (3) OF THE ORIGINAL SIX (6) ISOLATES OBTAINED THE EXPECTED RESULTS. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.A BIOMERIEUX INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11123925 ↗
• MalfunctionJan 6, 2021False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN RESULTS FOR STAPHYLOCOCCUS AUREUS FOR SIX (6) DIFFERENT PATIENTS IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT (REF 415670, LOT 2751438113). THE CUSTOMER STATED THAT CEFOXITIN SCREEN RESULTS WERE POSITIVE WHILE THE OXACILLIN RESULTS WERE SUSCEPTIBLE (MIC<=0.25 OR =0.5), BUT AES (ADVANCED EXPERT SYSTEM¿) CORRECTED THE INTERPRETATION FOR OXACILLIN TO RESISTANT BASED ON THE POSITIVE CEFOXITIN SCREEN RESULTS. THE CUSTOMER DOES NOT PERFORM ANY ALTERNATIVE METHOD FOR CEFOXITIN SCREEN, BUT DISK DIFFUSION TESTING FOR OXACILLIN WAS PERFORMED AND OBTAINED SUSCEPTIBLE RESULTS. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE AND CLEANED THE INSTRUMENT'S OPTICS AND CHECKED THE ALIGNMENT. THE CUSTOMER REPORTED THAT THEY HAVE NOT OBTAINED ANY DISCREPANT CEFOXITIN SCREEN RESULTS SINCE THE OPTICS CLEANING AND ALIGNMENT. RETEST OF THREE (3) OF THE ORIGINAL SIX (6) ISOLATES OBTAINED THE EXPECTED RESULTS. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMERIEUX INVESTIGATION HAS BEEN INITIA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11123897 ↗
• MalfunctionJan 6, 2021False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN RESULTS FOR STAPHYLOCOCCUS AUREUS FOR SIX (6) DIFFERENT PATIENTS IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT (REF 415670, LOT 2751438113). THE CUSTOMER STATED THAT CEFOXITIN SCREEN RESULTS WERE POSITIVE WHILE THE OXACILLIN RESULTS WERE SUSCEPTIBLE (MIC<=0.25 OR =0.5), BUT AES (ADVANCED EXPERT SYSTEM¿) CORRECTED THE INTERPRETATION FOR OXACILLIN TO RESISTANT BASED ON THE POSITIVE CEFOXITIN SCREEN RESULTS. THE CUSTOMER DOES NOT PERFORM ANY ALTERNATIVE METHOD FOR CEFOXITIN SCREEN, BUT DISK DIFFUSION TESTING FOR OXACILLIN WAS PERFORMED AND OBTAINED SUSCEPTIBLE RESULTS. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE AND CLEANED THE INSTRUMENT'S OPTICS AND CHECKED THE ALIGNMENT. THE CUSTOMER REPORTED THAT THEY HAVE NOT OBTAINED ANY DISCREPANT CEFOXITIN SCREEN RESULTS SINCE THE OPTICS CLEANING AND ALIGNMENT. RETEST OF THREE (3) OF THE ORIGINAL SIX (6) ISOLATES OBTAINED THE EXPECTED RESULTS. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMERIEUX INVESTIGATION HAS BEEN INITIA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11123886 ↗
• MalfunctionJan 6, 2021False Positive Result; False Positive Result

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN RESULTS FOR (B)(6) FOR SIX (6) DIFFERENT PATIENTS IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT (REF (B)(4), LOT (B)(4). THE CUSTOMER STATED THAT CEFOXITIN SCREEN RESULTS WERE POSITIVE WHILE THE OXACILLIN RESULTS WERE SUSCEPTIBLE (MIC<=0.25 OR =0.5), BUT AES (ADVANCED EXPERT SYSTEM¿) CORRECTED THE INTERPRETATION FOR OXACILLIN TO RESISTANT BASED ON THE POSITIVE CEFOXITIN SCREEN RESULTS. THE CUSTOMER DOES NOT PERFORM ANY ALTERNATIVE METHOD FOR CEFOXITIN SCREEN, BUT DISK DIFFUSION TESTING FOR OXACILLIN WAS PERFORMED AND OBTAINED SUSCEPTIBLE RESULTS. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE AND CLEANED THE INSTRUMENT'S OPTICS AND CHECKED THE ALIGNMENT. THE CUSTOMER REPORTED THAT THEY HAVE NOT OBTAINED ANY DISCREPANT CEFOXITIN SCREEN RESULTS SINCE THE OPTICS CLEANING AND ALIGNMENT. RETEST OF THREE (3) OF THE ORIGINAL SIX (6) ISOLATES OBTAINED THE EXPECTED RESULTS.THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.A BIOMERIEUX INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11123868 ↗
• MalfunctionJan 6, 2021False Positive Result; False Positive Result

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN RESULTS FOR (B)(6) FOR SIX (6) DIFFERENT PATIENTS IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT (REF 415670, LOT 2751438113). THE CUSTOMER STATED THAT CEFOXITIN SCREEN RESULTS WERE POSITIVE WHILE THE OXACILLIN RESULTS WERE SUSCEPTIBLE (MIC=0.25 OR =0.5), BUT AES (ADVANCED EXPERT SYSTEM¿) CORRECTED THE INTERPRETATION FOR OXACILLIN TO RESISTANT BASED ON THE POSITIVE CEFOXITIN SCREEN RESULTS. THE CUSTOMER DOES NOT PERFORM ANY ALTERNATIVE METHOD FOR CEFOXITIN SCREEN, BUT DISK DIFFUSION TESTING FOR OXACILLIN WAS PERFORMED AND OBTAINED SUSCEPTIBLE RESULTS. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE AND CLEANED THE INSTRUMENT'S OPTICS AND CHECKED THE ALIGNMENT. THE CUSTOMER REPORTED THAT THEY HAVE NOT OBTAINED ANY DISCREPANT CEFOXITIN SCREEN RESULTS SINCE THE OPTICS CLEANING AND ALIGNMENT. RETEST OF THREE (3) OF THE ORIGINAL SIX (6) ISOLATES OBTAINED THE EXPECTED RESULTS. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMERIEUX INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11123848 ↗
• MalfunctionJan 4, 2021False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A QUALITY CONTROL FAILURE, FALSE POSITIVE CEFOXITIN SCREEN TEST FOR S. AUREUS ATCC® 29213¿ STRAIN IN ASSOCIATION WITH VITEK® 2 AST-GP75 TEST KIT 20 CARDS ¿ (REF. 415670), LOT. #2751438113. THE EXPECTED RESULT IS CEFOXITIN SCREEN NEGATIVE. IT SHOULD BE NOTED THAT THIS CUSTOMER ALREADY REPORTED THE SAME QC FAILURE FOR THIS ATCC STRAIN USING A DIFFERENT LOT. GCS (GLOBAL CUSTOMER SERVICE) SUGGESTED TO THE CUSTOMER TO REPEAT TESTING WITH THE FOLLOWING RECOMMENDATIONS: CLEAN THE OPTICS OF THE INSTRUMENT. OBTAIN A NEW CULTILOOP. STREAK TO SBA AND INCUBATE IN 35 DEGREES CELSIUS IN CO2. CHECK FOR PURITY. REPEAT STREAK TO SBA FOR 24 HOURS. PLACE ON THE INSTRUMENT. REPEAT TESTING FOLLOWING THOSE RECOMMENDATIONS STILL RESULTED IN QC FAILURE. THEREFORE, THE OPTICS WERE CHANGED AT THE CUSTOMER SITE AND SINCE THIS REPLACEMENT, THE CUSTOMER DOES NOT ENCOUNTER THE ISSUE ANYMORE. THERE IS NO PATIENT ASSOCIATED WITH THIS QC ISOLATE; THEREFORE, 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 11113377 ↗
• MalfunctionDec 22, 2020False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF OBTAINING A FALSE POSITIVE CEFOXITIN SCREEN RESULT FOR STAPHYLOCOCCUS AUREUS ATCC® 259213¿ IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT (REF. 415670, LOT 2751557403). THE S. AUREUS ATCC® 259213¿ ISOLATE WAS CULTURED ON SHEEP BLOOD AGAR AND INCUBATED WITHOUT CARBON DIOXIDE AT 35°C FOR 24 HOURS PRIOR TO TESTING. THE VITEK 2 TESTING WAS THEN PERFORMED WITH LOT 2751557403 AND OBTAINED A POSITIVE CEFOXITIN SCREEN RESULT. THE CUSTOMER CONFIRMED THE EXPECTED CEFOXITIN SCREEN RESULT S. AUREUS ATCC® 259213¿ IS NEGATIVE. THE CUSTOMER CLEANED THE INSTRUMENT OPTICS THEN PERFORMED REPEAT TESTING USING A FRESH CULTILOOP CULTURED ON SHEEP BLOOD AGAR INCUBATED AT 35°C WITH CARBON DIOXIDE FOR 24 HOURS. THE EXPECTED NEGATIVE CEFOXITIN SCREEN RESULT WAS OBTAINED. IT SHOULD BE NOTED THAT STAPHYLOCOCCUS AUREUS CAN BE INCUBATED WITH OR WITHOUT CARBON DIOXIDE ON SHEEP BLOOD AGAR ACCORDING TO THE PACKAGE INSERT CULTURE REQUIREMENTS TABLE. 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 11059394 ↗
• MalfunctionOct 1, 2020False Positive Result; False Positive Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE POSITIVE CEFOXITIN SCREEN RESULT FOR A STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT (REF. 415670, LOT 2751392103), AS COMPARED TO KIRBY-BAUER (KB). THE CUSTOMER STATED THE PATIENT WAS FLAGGED BY THE HOSPITAL AS PRESUMPTIVE MRSA POSITIVE, WAS PLACED IN ISOLATION WITH OTHER MRSA POSITIVE PATIENTS. SUMMARY: VITEK AST-GP75 (INITIAL): CEFOXITIN SCREEN POSITIVE, OXACILLIN TESTED SUSCEPTIBLE (S) WITH THERAPEUTIC CORRECTION TO RESISTANT (R). VITEK AST-GP75 (REPEAT): NO REPEAT RESULTS WERE PROVIDED BY THE CUSTOMER. ALTERNATE SUSCEPTIBILITY TEST: KB CEFOXITIN DISK - SUSCEPTIBLE. 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 10616553 ↗
• MalfunctionSep 28, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN FOR STAPHYLOCOCCUS AUREUS ATCC® 29213¿ WHILE PERFORMING INTERNAL QUALITY CONTROL TESTING USING THE VITEK® 2 AST-GP75 TEST KIT (REF 415670, LOT 2751438113). IN ADDITION TO THE FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN RESULT, THE TEST ALSO OBTAINED OUT OF RANGE HIGH (OORH) DAPTOMYCIN RESULTS. 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 10593960 ↗
• MalfunctionSep 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN RESULTS FOR STAPHYLOCOCCUS AUREUS ATCC® 29213¿ WHILE PERFORMING INTERNAL QUALITY CONTROL TESTING WITH THE VITEK® 2 AST-GP75 TEST KIT (REF 415670, LOT 2751392103). INITIAL AND REPEAT ANALYSIS OBTAINED POSITIVE (RESISTANT) CEFOXITIN SCREEN RESULTS. VITEK® 2: CEFOXITIN SCREEN = POSITIVE (RESISTANT). EXPECTED: CEFOXITIN SCREEN = NEGATIVE (SUSCEPTIBLE). TROUBLESHOOTING PERFORMED BY LOCAL CUSTOMER SERVICE (LCS) PROVIDED THE CUSTOMER WITH SOME SUGGESTIONS FOR IMPROVING THEIR SET UP, BUT THE CEFOXITIN SCREEN RESULTS OBTAINED WERE STILL POSITIVE (RESISTANT). A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE ON 20AUG2020 AND REPLACED THE OPTICS ON THE VITEK® 2 INSTRUMENT. THE CUSTOMER PERFORMED ADDITIONAL QUALITY CONTROL TESTING WITH LOT 2751392103 AFTER THE FSE REPLACED THE OPTICS AND OBTAINED FALSE POSITIVE CEFOXITIN SCREEN RESULTS. AS THIS DISCREPANCY OCCURRED DURING QUALITY CONTROL TESTING, THERE IS NO PATIENT INVOLVED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 10514898 ↗
• MalfunctionAug 6, 2020False Negative Result; False Negative Result

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMERIEUX OF A FALSE NEGATIVE (SUSCEPTIBLE) CEFOXITIN SCREEN (OXFS) RESULT FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP75 TEST KIT 20 CARDS (REF. 415670, LOT 2751408403). VITEK® 2 REPORTED TWICE OXACILLIN (OX) SUSCEPTIBLE AND CEFOXITIN SCREEN (OXSF) NEGATIVE. THE CUSTOMER SENT THE ISOLATE OUT TO CEPHEID, AND THE EXPECTED RESULT WAS OBTAINED AS METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). SUMMARY: S. AUREUS ISOLATE, AST-GP75, LOT 2751408403, INITIAL TEST: OX MIC=2, SUSCEPTIBLE / OXSF=NEGATIVE, *REPEAT TEST: OX MIC=2, SUSCEPTIBLE / OXSF=NEGATIVE, ALTERNATIVE TEST: GENEXPERT= MRSA, THE CUSTOMER MANUALLY CHANGED THE OX AND OXSF RESULT TO RESISTANT AND POSITIVE RESPECTIVELY. GLOBAL CUSTOMER SERVICE (GCS) REVIEWED THE CUSTOMER¿S TROUBLESHOOTING FORM AND DID NOT IDENTIFY ANY OFF-LABEL USE. THERE IS NO INDICATION FROM THE CUSTOMER THAT THIS EVENT IMPACTED THE PATIENT¿S STATE OF HEALTH OR LED TO A DELAY OF RESULTS. A SEPARATE CASE (B)(4) WAS CREATED FOR THE OX SUSCEPTIBLE RESULTS OBTAINED BY VITEK® 2 LOT 2751408403. A BIOMERIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10373674 ↗
• MalfunctionDec 17, 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 (OX) RESULT (MIC>=4) FOR A PATIENT STAPHYLOCOCCUS AUREUS STRAIN (SOURCE=BLOOD) IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT. REPEAT TESTING OBTAINED THE SAME OX RESISTANT RESULT. THE CUSTOMER SENT THE ISOLATE TO A REFERENCE LABORATORY FOR CONFIRMATORY TESTING. THE REFERENCE LAB OBTAINED A RESULT OF OX SUSCEPTIBLE (MIC<=0.25) VIA AGAR DILUTION (AD), AND TESTED THE ISOLATE MECA NEGATIVE VIA VERIGENE. THE CUSTOMER PERFORMED VITEK 2 TESTING FROM OTHER BODY SITES WITH THE SAME OX RESULTS. THE CUSTOMER STATED THE PATIENT IS CURRENTLY BEING TREATED WITH VANCOMYCIN. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR TREATING PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9484160 ↗
• MalfunctionNov 27, 2019False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A FALSE POSITIVE CEFOXITIN SCREEN RESULT FOR A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT (REF 415670). NO LOT NUMBERS OR LAB REPORTS WERE PROVIDED BY THE CUSTOMER. THE CUSTOMER PERFORMED PBP2A TESTING AS AN ALTERNATIVE METHOD AND OBTAINED NEGATIVE RESULTS. REPEAT ANALYSIS WITH THE VITEK® 2 AST-GP75 TEST KIT OBTAINED NEGATIVE CEFOXITIN SCREEN RESULTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY 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 9384350 ↗
• MalfunctionNov 1, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF RECEIVING FALSE POSITIVE CEFOXITIN SCREEN RESULTS FOR STAPHYLOCOCCUS AUREUS FOR TWO ISOLATES FROM TWO DIFFERENT PATIENTS WHEN TESTING WITH THE VITEK® 2 AST-GP75 TEST KIT (REF 415670, LOT 2751103203). CEFOXITIN (FOX) DISK DIFFUSION TESTING WAS PERFORMED AS AN ALTERNATIVE METHOD AND OBTAINED SUSCEPTIBLE RESULTS FOR BOTH ISOLATES. THE CUSTOMER REPORTED THAT THE FALSE POSITIVE CEFOXITIN SCREEN RESULTS DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO EITHER PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9266476 ↗
• MalfunctionNov 1, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF RECEIVING FALSE POSITIVE CEFOXITIN SCREEN RESULTS FOR STAPHYLOCOCCUS AUREUS FOR TWO ISOLATES FROM TWO DIFFERENT PATIENTS WHEN TESTING WITH THE VITEK® 2 AST-GP75 TEST KIT (REF 415670, LOT 2751103203). CEFOXITIN (FOX) DISK DIFFUSION TESTING WAS PERFORMED AS AN ALTERNATIVE METHOD AND OBTAINED SUSCEPTIBLE RESULTS FOR BOTH ISOLATES. THE CUSTOMER REPORTED THAT THE FALSE POSITIVE CEFOXITIN SCREEN RESULTS DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO EITHER PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9266475 ↗
• MalfunctionSep 16, 2019False Negative Result; False Negative Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE CEFOXITIN SCREEN (OXSF) RESULT FOR A PATIENT STAPHYLOCOCCUS AUREUS WOUND ISOLATE WHILE USING THE VITEK® 2 AST-GP75 TEST KIT (REFERENCE 415670, LOT 2751099203). THE ISOLATE WAS REPEATED ON THE VITEK 2 USING THE SAME LOT OF CARDS AND TESTED USING GENEXPERT® PCR. THE VITEK 2 OBTAINED A NEGATIVE CEFOXITIN SCREEN RESULT HOWEVER; THE GENEXPERT PCR RESULT WAS OXSF POSITIVE. 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. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9072385 ↗
• MalfunctionSep 4, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE RESISTANT OXACILLIN RESULTS FOR A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE WHEN TESTING WITH THE VITEK® 2 AST-GP75 TEST KIT (REF 415670, LOT 2750973203). THE ISOLATE WAS COLLECTED FROM A NASOPHARYNGEAL SAMPLE. THE INITIAL AND FIRST REPEAT TEST OBTAINED THE SAME OXACILLIN RESULTS OF MIC > 4 (RESISTANT). WHEN TESTING WAS REPEATED A WEEK LATER, THE OXACILLIN RESULT WAS MIC 0.5 (SUSCEPTIBLE). INITIAL: CEFOXITIN SCREEN = NEG (AES MODIFIED TO POS). OXACILLIN = > 4 (RESISTANT). MRSA PCR = NEG. PBP2A = NEG. REPEAT 1: CEFOXITIN SCREEN = NEG (AES MODIFIED TO POS). OXACILLIN = > 4 (RESISTANT). MRSA PCR = NEG. PBP2A = NEG. REPEAT 2 (1 WEEK LATER): CEFOXITIN SCREEN = NEG. OXACILLIN = (B)(6). PBP2A = NEG. (B)(6) PCR = (B)(6). THE CUSTOMER REPORTED THAT THE DISCREPANT RESULTS DID NOT LEAD TO ANY ADVERSE IMPACT ON THE PATIENT'S HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8959930 ↗
• MalfunctionJul 16, 2019False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE CEFOXITIN SCREEN WHEN TESTING TWO STAPHYLOCOCCUS AUREUS PATIENT ISOLATES WITH THE VITEK® 2 AST-GP75 TEST KIT (REFERENCE # 415670, LOT # 2751063103). UPON REPEAT TESTING THE SAME RESULTS WERE OBTAINED. CUSTOMER LOT # 2751063103: OXACILLIN MIC = 0.5, SUSCEPTIBLE (MODIFIED TO RESISTANT BY ADVANCED EXPERT SYSTEM¿) FOR ALL 4 RESULTS. THE CUSTOMER TESTED THE STRAINS A THIRD TIME WITH THE SAME LOT (LOT # 2751063103) AND A SECOND LOT (LOT # 2751069103). ALL CEFOXITIN SCREEN RESULTS WERE NEGATIVE. CUSTOMER LOT # 2751063103: OXACILLIN MIC <= 0.25, SUSCEPTIBLE. OXACILLIN MIC = 0.5, SUSCEPTIBLE. SECOND LOT # 2751069103: OXACILLIN MIC = 0.5, SUSCEPTIBLE. OXACILLIN MIC = 0.5, SUSCEPTIBLE. ALTERNATE TESTING WAS PERFORMED WITH PBP2A AND RESULTS WERE SUSCEPTIBLE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED. ON 15-JUL-2019, BIOMÉRIEUX BECAME AWARE THAT THE TWO ISOLATES WERE FROM TWO SEPARATE PATIENTS. THIS MEDWATCH REPORT 1950204-2019-00230 RELATES TO THE SECOND PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8793783 ↗
• MalfunctionJul 11, 2019False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE CEFOXITIN SCREEN WHEN TESTING TWO STAPHYLOCOCCUS AUREUS PATIENT ISOLATES WITH THE VITEK® 2 AST-GP75 TEST KIT (REFERENCE # 415670, LOT # 2751063103). UPON REPEAT TESTING THE SAME RESULTS WERE OBTAINED. CUSTOMER LOT # 2751063103: OXACILLIN MIC = 0.5, SUSCEPTIBLE (MODIFIED TO RESISTANT BY ADVANCED EXPERT SYSTEM¿) FOR ALL 4 RESULTS. THE CUSTOMER TESTED THE STRAINS A THIRD TIME WITH THE SAME LOT (LOT # 2751063103) AND A SECOND LOT (LOT # 2751069103). ALL CEFOXITIN SCREEN RESULTS WERE NEGATIVE. CUSTOMER LOT # 2751063103: OXACILLIN MIC <= 0.25, SUSCEPTIBLE. OXACILLIN MIC = 0.5, SUSCEPTIBLE. SECOND LOT # 2751069103: OXACILLIN MIC = 0.5, SUSCEPTIBLE. OXACILLIN MIC = 0.5, SUSCEPTIBLE. ALTERNATE TESTING WAS PERFORMED WITH PBP2A AND RESULTS WERE SUSCEPTIBLE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8781718 ↗
• MalfunctionMay 22, 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 (B)(6) CEFOXITIN SCREEN RESULT OF A STAPHYLOCOCCUS AUREUS ISOLATE WHILE USING THE VITEK® 2 AST-GP75 TEST KIT (REF # (B)(4), LOT# 2750996203) WITH SOFTWARE VERSION 9.01. THE PATIENT ISOLATE WAS REPEATED USING THE SAME LOT OF AST-GP75 CARDS AND WAS ALSO TESTED USING CEPHIDAE GENEXPERT® PCR. THE RESULTS ARE LISTED BELOW: ISOLATE RESULTS: VITEK 2 ORIGINAL CEFOXITIN SCREEN RESULT - (B)(6) (SUSCEPTIBLE). VITEK 2 REPEAT CEFOXITIN SCREEN RESULT - (B)(6) (SUSCEPTIBLE). CEPHIDAE GENEXPERT PCR RESULT - (B)(6) (RESISTANT). 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. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8631484 ↗
• MalfunctionApr 18, 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 POSITIVE CEFOXITIN SCREEN FOR STAPHYLOCOCCUS AUREUS WHEN PERFORMING ANTIBIOTIC SUSCEPTIBILITY TESTING ON QC STRAIN ATCC 29213 WHEN USING THE VITEK® 2 AST-GP75 TEST KIT (REFERENCE 415670), LOT 2750951203. THE CUSTOMER OBTAINED THE FOLLOWING RESULTS FOR THE QC STRAIN: EXPECTED ORGANISM: ATCC 29213, STAPHYLOCOCCUS AUREUS. INITIAL VITEK 2 AST-GP75 CARD: ON (B)(6) 2019: CEFOXITIN SCREEN, POSITIVE. REPEAT VITEK 2 AST-GP75 CARD: ON (B)(6) 2019: CEFOXITIN SCREEN, POSITIVE. ON (B)(6) 2019: CEFOXITIN SCREEN, POSITIVE. ON (B)(6) 2019: CEFOXITIN SCREEN, NEGATIVE. ON (B)(6) 2019: CEFOXITIN SCREEN, NEGATIVE. THE CUSTOMER REPORTED THAT THE DENSICHEK WAS CALIBRATED, AND THAT TRYPTICASE SOY AGAR WITH BLOOD WAS USED TO PREPARE SUBCULTURES, AT AN 18-24 HOUR INCUBATION AT 35-36°C, UNDER NON-CO2 CONDITIONS. AS THE CUSTOMER'S STRAIN WAS A QUALITY CONTROL STRAIN, NO PATIENT RESULTS WERE REPORTED. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 8529681 ↗
• MalfunctionMar 27, 2019False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE CEFOXITIN SCREEN (OXFS) RESULTS FOR TWO STRAINS WHILE USING THE VITEK® 2 AST-GP75 TEST KIT (REF# 415670, LOT# 2750865203). 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 ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8458218 ↗
• MalfunctionMar 27, 2019False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE CEFOXITIN SCREEN (OXFS) RESULTS FOR TWO STRAINS WHILE USING THE VITEK® 2 AST-GP75 TEST KIT (REF # 415670, LOT#2750865203). 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 ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8458214 ↗
• MalfunctionMar 27, 2019False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE CEFOXITIN SCREEN (OXFS) RESULTS WHILE USING THE VITEK® 2 AST-GP75 TEST KIT (REF # 415670 LOT# 2750899403). THE CUSTOMER PROVIDED LAB RESULTS FROM FIVE STRAINS. THE RESULTS OBTAINED FOR STRAIN 5 ARE AS FOLLOWS: STRAIN 5: INITIAL TEST WITH GP75 LOT 2750899403: OXFS POSITIVE, OXACILLIN S->R; REPEAT TEST WITH SAME LOT: OXFS POSITIVE, OXACILLIN S->R; REPEAT TEST WITH GP75 LOT 2750865203: OXFS NEGATIVE. 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 ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8457017 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032399, K032766, K050976, K053097, K072668, K072695, K080201, K091126, K093076, K122547, N50510. One submission often covers many models, so check the product and lot details in each record.

• Z-0792-2023 · Nov 9, 2022 · Open, Classified
  VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226
• 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