VITEK® 2 AST-GP78Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 03573026554569), received between Oct 8, 2018 and Dec 17, 2020 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (31 reports).

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

1 other recall cover devices cleared under the same FDA submission (K031865, K032766, K050976, K053097, K072668, K072695, K080201, K091126, K122547, K141149, 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-0850-2023 · 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2020False Positive Result; False Positive Result

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE CEFOXITIN SCREEN RESULT FOR A STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP78 TEST KIT (REF. 421051, LOT 2781427403) AND SOFTWARE VERSION 9.02. THE CUSTOMER STATED THE S. AUREUS ISOLATE OBTAINED AN OXACILLIN MIC= 0.5 SUSCEPTIBLE; THIS RESULT WAS THEN MODIFIED TO RESISTANT BASED UPON THE POSITIVE CEFOXITIN SCREEN RESULT. BIOMERIEUX CUSTOMER SERVICE REQUESTED INFORMATION REGARDING ALTERNATE SUSCEPTIBILITY TESTING; THIS INFORMATION HAS NOT YET BEEN PROVIDED. REPEAT TESTING WAS CONDUCTED AND THE EXPECTED NEGATIVE RESULT WAS OBTAINED. 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. BIOMERIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11030475 ↗
• MalfunctionDec 17, 2020False Positive Result; False Positive Result

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOM¿RIEUX OF OBTAINING A FALSE POSITIVE CEFOXITIN SCREEN RESULT FOR A STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK¿ 2 AST-GP78 TEST KIT (REF. 421051, LOT 2781427403) AND SOFTWARE VERSION (B)(4). THE CUSTOMER STATED THE S. AUREUS ISOLATE OBTAINED AN OXACILLIN MIC= 0.5 SUSCEPTIBLE; THIS RESULT WAS THEN MODIFIED TO RESISTANT BASED UPON THE POSITIVE CEFOXITIN SCREEN RESULT. BIOMERIEUX CUSTOMER SERVICE REQUESTED INFORMATION REGARDING ALTERNATE SUSCEPTIBILITY TESTING; THIS INFORMATION HAS NOT YET BEEN PROVIDED. REPEAT TESTING WAS CONDUCTED AND THE EXPECTED NEGATIVE RESULT WAS OBTAINED. 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. BIOMERIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11030422 ↗
• MalfunctionOct 28, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781427403). THIS SAME CUSTOMER HAD PREVIOUSLY NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE OXSF RESULTS WHILE TESTING S. AUREUS WITH AST-GP78 LOT 2781335403 (MDRS 1950204-2020-00154 THROUGH 1950204-2020-00168 WERE SUBMITTED FOR THAT INCIDENT) AND AST-GP78 LOT 2781357203 (MDRS 1950204-2020-00175 THROUGH 1950204-2020-00181 WERE SUBMITTED FOR THOSE ISOLATES). AN INTERNAL BIOMÉRIEUX INVESTIGATION IS CURRENTLY UNDERWAY. NONE OF THE PATIENT ISOLATES FROM THESE EVENTS WERE AVAILABLE FOR SUBMITTAL. ONLY A QC STRAIN WAS PREVIOUSLY SUBMITTED FOR THE INVESTIGATION. THE CUSTOMER HAD BEEN ASKED TO RETAIN AND SUBMIT ANY FUTURE STAPHYLOCOCCUS AUREUS ISOLATES FOR WHICH THEY OBTAIN A FALSE POSITIVE OXSF RESULT. THE CUSTOMER HAS SINCE NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE OXSF RESULTS FOR THREE STAPHYLOCOCCUS AUREUS ISOLATES WHEN TESTING WITH AST-GP78, LOT 2781427403. ISOLATE 21692428 WAS REPORTED TO BIOMÉRIEUX ON 21SEP2020 (MDR 1950204-2020-00198). ISOLATE (B)(4)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10748475 ↗
• MalfunctionOct 22, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781427403). THIS SAME CUSTOMER HAD PREVIOUSLY NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE OXSF RESULTS WHILE TESTING S. AUREUS WITH AST-GP78 LOT 2781335403 (MDRS 1950204-2020-00154 THROUGH 1950204-2020-00168 WERE SUBMITTED FOR THAT INCIDENT) AND AST-GP78 LOT 2781357203 (MDRS 1950204-2020-00175 THROUGH 1950204-2020-00181 WERE SUBMITTED FOR THOSE ISOLATES). AN INTERNAL BIOMÉRIEUX INVESTIGATION IS CURRENTLY UNDERWAY. NONE OF THE PATIENT ISOLATES FROM THESE EVENTS WERE AVAILABLE FOR SUBMITTAL. ONLY A QC STRAIN WAS PREVIOUSLY SUBMITTED FOR THE INVESTIGATION. THE CUSTOMER HAD BEEN ASKED TO RETAIN AND SUBMIT ANY FUTURE STAPHYLOCOCCUS AUREUS ISOLATES FOR WHICH THEY OBTAIN A FALSE POSITIVE OXSF RESULT. THE CUSTOMER HAS SINCE NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE OXSF RESULTS FOR TWO STAPHYLOCOCCUS AUREUS ISOLATES WHEN TESTING WITH AST-GP78, LOT 2781427403. ON 25SEP2020, THE CUSTOMER INFORMED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE OXSF RESULTS FOR STAPHYL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10718778 ↗
• MalfunctionOct 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOM¿RIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK¿ 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781427403). THIS SAME CUSTOMER HAD PREVIOUSLY NOTIFIED BIOM¿RIEUX OF OBTAINING FALSE POSITIVE OXSF RESULTS WHILE TESTING S. AUREUS WITH AST-GP78 LOT 2781335403 (SEE (B)(4), MDRS 1950204-2020-00154 THROUGH 1950204-2020-00168 WERE SUBMITTED FOR THAT INCIDENT) AND AST-GP78 LOT 2781357203 (SEE (B)(4), MDRS 1950204-2020-00175 THROUGH 1950204-2020-00181 WERE SUBMITTED FOR THOSE ISOLATES). AN INTERNAL BIOM¿RIEUX INVESTIGATION IS CURRENTLY UNDERWAY. NONE OF THE PATIENT ISOLATES FROM THESE EVENTS WERE AVAILABLE FOR SUBMITTAL. ONLY A QC STRAIN WAS PREVIOUSLY SUBMITTED FOR THE INVESTIGATION. THE CUSTOMER HAD BEEN ASKED TO RETAIN AND SUBMIT ANY FUTURE STAPHYLOCOCCUS AUREUS ISOLATES FOR WHICH THEY OBTAIN A FALSE POSITIVE OXSF RESULT. THE CUSTOMER HAS SINCE NOTIFIED BIOM¿RIEUX OF OBTAINING FALSE POSITIVE OXSF RESULTS FOR TWO STAPHYLOCOCCUS AUREUS ISOLATES WHEN TESTING WITH AST-GP78, LOT 2781427403. ON 21SEP2020, THE CUSTOMER INFORMED BIOM¿RIEUX OF OBTAINING FALSE POSITIVE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10715216 ↗
• MalfunctionSep 24, 2020False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE CEFOXITIN SCREEN RESULT FOR TWO PATIENT STAPHYLOCOCCUS AUREUS ISOLATES IN ASSOCIATION WITH THE VITEK® 2 AST-GP78 TEST KIT (REF. 421051, LOT 2781357203). FIELD APPLICATION SPECIALIST (FAS) ARRIVED ON SITE TO PERFORM REPEAT TESTING AND SET UP TESTING PER MANUFACTURER GUIDELINES. ALL ISOLATES RESULTED IN NEGATIVE CEFOXITIN SCREENS AND AGREED WITH THE PBP2A TEST. SUMMARY: PATIENT #2: (B)(6). VITEK® 2 AST-GP78 RESULTS: INITIAL: (GP78 LOT 2781357203): CEFOXITIN SCREEN POSITIVE. REPEAT: (GP78 LOT 2781427403): CEFOXITIN SCREEN NEGATIVE. ALTERNATE TEST RESULT: PBP2A NEGATIVE. EXPECTED RESULT: CEFOXITIN SCREEN NEGATIVE, (B)(6). 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 10581237 ↗
• MalfunctionSep 24, 2020False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE CEFOXITIN SCREEN RESULT FOR TWO PATIENT (B)(6) ISOLATES IN ASSOCIATION WITH THE VITEK® 2 AST-GP78 TEST KIT (REF. 421051, LOT 2781357203). FIELD APPLICATION SPECIALIST (FAS) ARRIVED ON SITE TO PERFORM REPEAT TESTING AND SET UP TESTING PER MANUFACTURER GUIDELINES. ALL ISOLATES RESULTED IN (B)(6) CEFOXITIN SCREENS AND AGREED WITH THE PBP2A TEST. SUMMARY: PATIENT #1:(B)(4). VITEK® 2 AST-GP78 RESULTS: INITIAL: (GP78 LOT 2781357203): CEFOXITIN SCREEN (B)(6). REPEAT: (GP78 LOT 2781427403): CEFOXITIN SCREEN (B)(6). ALTERNATE TEST RESULT: PBP2A (B)(6). EXPECTED RESULT: CEFOXITIN SCREEN (B)(6). 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 10581218 ↗
• MalfunctionSep 24, 2020False Positive Result; False Positive Result

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE CEFOXITIN SCREEN RESULT FOR THREE PATIENT STAPHYLOCOCCUS AUREUS ISOLATES IN ASSOCIATION WITH THE VITEK® 2 AST-GP78 TEST KIT (REF. 421051, LOT 2781427403). FIELD APPLICATION SPECIALIST (FAS) ARRIVED ON SITE TO PERFORM REPEAT TESTING AND SET UP TESTING PER MANUFACTURER GUIDELINES. ALL ISOLATES RESULTED IN NEGATIVE CEFOXITIN SCREENS AND AGREED WITH THE PBP2A TEST. SUMMARY:PATIENT #3: (B)(6). VITEK® 2 AST-GP78, RESULTS: INITIAL: (GP78 LOT 2781427403): CEFOXITIN SCREEN POSITIVE, REPEAT: (GP78 LOT 2781427403): CEFOXITIN SCREEN NEGATIVE. ALTERNATE TEST RESULT: PBP2A NEGATIVE. EXPECTED RESULT: CEFOXITIN SCREEN NEGATIVE, MSSA. 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 10581198 ↗
• MalfunctionSep 24, 2020False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE CEFOXITIN SCREEN RESULT FOR THREE PATIENT STAPHYLOCOCCUS AUREUS ISOLATES IN ASSOCIATION WITH THE VITEK® 2 AST-GP78 TEST KIT (REF. 421051, LOT 2781427403). FIELD APPLICATION SPECIALIST (FAS) ARRIVED ON SITE TO PERFORM REPEAT TESTING AND SET UP TESTING PER MANUFACTURER GUIDELINES. ALL ISOLATES RESULTED IN NEGATIVE CEFOXITIN SCREENS AND AGREED WITH THE PBP2A TEST. SUMMARY: PATIENT #2: (B)(4) VITEK® 2 AST-GP78 RESULTS: INITIAL: (GP78 LOT 2781427403): CEFOXITIN SCREEN POSITIVE REPEAT: (GP78 LOT 2781427403): CEFOXITIN SCREEN NEGATIVE ALTERNATE TEST RESULT: PBP2A NEGATIVE EXPECTED RESULT: CEFOXITIN SCREEN NEGATIVE, MSSA 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 10581186 ↗
• MalfunctionSep 24, 2020False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE CEFOXITIN SCREEN RESULT FOR THREE PATIENT STAPHYLOCOCCUS AUREUS ISOLATES IN ASSOCIATION WITH THE VITEK® 2 AST-GP78 TEST KIT (REF. (B)(4), LOT 2781427403). FIELD APPLICATION SPECIALIST (FAS) ARRIVED ON SITE TO PERFORM REPEAT TESTING, AND SET UP TESTING PER MANUFACTURER GUIDELINES. ALL ISOLATES RESULTED IN NEGATIVE CEFOXITIN SCREENS AND AGREED WITH THE PBP2A TEST. SUMMARY: PATIENT #1: (B)(6). VITEK® 2 AST-GP78 RESULTS: INITIAL: (GP78 LOT 2781427403): CEFOXITIN SCREEN POSITIVE. REPEAT: (GP78 LOT 2781427403): CEFOXITIN SCREEN NEGATIVE. ALTERNATE TEST RESULT: PBP2A NEGATIVE. EXPECTED RESULT: CEFOXITIN SCREEN NEGATIVE, MSSA. 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 10581178 ↗
• 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-GP78 TEST KIT (REF. 421051, LOT 2781427403) WHEN TESTING A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE. THE CUSTOMER STATED LOT 2781427403 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 REPEATED USING THE SAME CARD LOT AND WITH THE VITEK® 2 AST-GP67 TEST KIT (REF. 22226 LOT, 1321480203). BOTH CARD LOTS OBTAINED AN OXACILLIN MIC >=4 RESISTANT. REFER TO CN-091084 FOR FALSE RESISTANT RESULT ASSOCIATED WITH LOT 1321480203. THE CUSTOMER ALSO TESTED THE STAPHYLOCOCCUS AUREUS ISOLATE USING THE OXPLATE, PCR, AND PBP2A TEST METHODS. ALL ALTERNATIVE TEST METHODS OBTAINED A NEGATIVE 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 10572888 ↗
• MalfunctionSep 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMERIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781357203). THIS SAME CUSTOMER HAD PREVIOUSLY NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE OXSF RESULTS WHILE TESTING S. AUREUS WITH AST-GP78 LOT 2781335403 (MDRS 1950204-2020-00154 THROUGH 1950204-2020-00168 WERE SUBMITTED FOR THAT INCIDENT). THE CUSTOMER SWITCHED TO LOT 2781357203 AND NOTICED A DECREASE IN FALSE POSITIVE OXSF RESULTS, HOWEVER, THE DISCREPANT RESULTS STILL OCCURRED. THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE CEFOXITIN SCREEN RESULTS WITH FOUR (4) ISOLATES (MDRS 1950204-2020-00175 THROUGH 1950204-2020-00178 WERE SUBMITTED FOR THOSE ISOLATES). AN ON-SITE FIELD APPLICATION SPECIALIST (FAS) VISIT FOR TROUBLESHOOTING WAS COMPLETED INCLUDING A REVIEW OF THE CUSTOMER¿S SETUP PROCEDURES. NO OFF-LABEL USE OR USER SETUP ERRORS HAVE BEEN NOTED FOR THIS CUSTOMER. THE CUSTOMER NOTIFIED BIOMÉRIEUX OF THREE (3) MORE ISOLATES IMPACTED BY THIS ISSUE WITH LOT 2781357203 DURING THIS ON-SITE VISIT. SUMMARY: VITEK 2 AST-GP78, LOT 2781357203. S. AUREUS, IS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10551296 ↗
• MalfunctionSep 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMERIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781357203). THIS SAME CUSTOMER HAD PREVIOUSLY NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE OXSF RESULTS WHILE TESTING S. AUREUS WITH AST-GP78 LOT 2781335403 (MDRS 1950204-2020-00154 THROUGH 1950204-2020-00168 WERE SUBMITTED FOR THAT INCIDENT). THE CUSTOMER SWITCHED TO LOT 2781357203 AND NOTICED A DECREASE IN FALSE POSITIVE OXSF RESULTS; HOWEVER, THE DISCREPANT RESULTS STILL OCCURRED. THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE CEFOXITIN SCREEN RESULTS WITH FOUR (4) ISOLATES (MDRS 1950204-2020-00175 THROUGH 1950204-2020-00178 WERE SUBMITTED FOR THOSE ISOLATES). AN ON-SITE FIELD APPLICATION SPECIALIST (FAS) VISIT FOR TROUBLESHOOTING WAS COMPLETED INCLUDING A REVIEW OF THE CUSTOMER¿S SETUP PROCEDURES. NO OFF-LABEL USE OR USER SETUP ERRORS HAVE BEEN NOTED FOR THIS CUSTOMER. THE CUSTOMER NOTIFIED BIOMÉRIEUX OF THREE (3) MORE ISOLATES IMPACTED BY THIS ISSUE WITH LOT 2781357203 DURING THIS ON-SITE VISIT. SUMMARY: VITEK 2 AST-GP78, LOT 2781357203 S. AUREUS, ISO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10551291 ↗
• MalfunctionSep 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMERIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781357203). THIS SAME CUSTOMER HAD PREVIOUSLY NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE OXSF RESULTS WHILE TESTING S. AUREUS WITH AST-GP78 LOT 2781335403 (MDRS 1950204-2020-00154 THROUGH 1950204-2020-00168 WERE SUBMITTED FOR THAT INCIDENT). THE CUSTOMER SWITCHED TO LOT 2781357203 AND NOTICED A DECREASE IN FALSE POSITIVE OXSF RESULTS; HOWEVER, THE DISCREPANT RESULTS STILL OCCURRED. THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE CEFOXITIN SCREEN RESULTS WITH FOUR (4) ISOLATES (MDRS 1950204-2020-00175 THROUGH 1950204-2020-00178 WERE SUBMITTED FOR THOSE ISOLATES). AN ON-SITE FIELD APPLICATION SPECIALIST (FAS) VISIT FOR TROUBLESHOOTING WAS COMPLETED INCLUDING A REVIEW OF THE CUSTOMER¿S SETUP PROCEDURES. NO OFF-LABEL USE OR USER SETUP ERRORS HAVE BEEN NOTED FOR THIS CUSTOMER. THE CUSTOMER NOTIFIED BIOMÉRIEUX OF THREE (3) MORE ISOLATES IMPACTED BY THIS ISSUE WITH LOT 2781357203 DURING THIS ON-SITE VISIT. SUMMARY: VITEK 2 AST-GP78, LOT 2781357203. S. AUREUS, IS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10551278 ↗
• MalfunctionSep 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMERIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781357203). THIS SAME CUSTOMER HAD PREVIOUSLY NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE OXSF RESULTS WHILE TESTING S. AUREUS WITH AST-GP78 LOT 2781335403 (MDRS 1950204-2020-00154 THROUGH 1950204-2020-00168 WERE SUBMITTED FOR THAT INCIDENT). THE CUSTOMER SWITCHED TO LOT 2781357203 AND NOTICED A DECREASE IN FALSE POSITIVE OXSF RESULTS, HOWEVER, THE DISCREPANT RESULTS STILL OCCURRED. THE CUSTOMER REPORTED OBTAINING THESE DISCREPANT RESULTS WITH FOUR (4) ISOLATES. SUMMARY: ALL PATIENT ISOLATES=S. AUREUS; AST-GP78, LOT 2781357203; INITIAL: OXSF=POSITIVE; REPEAT: NOT PERFORMED; ALTERNATIVE TESTING BY FOX KB AND OX E-TEST CONFIRMED NEGATIVE; *NOTE: ABOVE INFORMATION PERTAINS TO ALL FOUR (4) ISOLATES. AN ON-SITE FIELD APPLICATION SPECIALIST (FAS) VISIT FOR TROUBLESHOOTING WAS COMPLETED INCLUDING A REVIEW OF THE CUSTOMER¿S SETUP PROCEDURES. NO OFF-LABEL USE OR USER SETUP ERRORS HAVE BEEN NOTED FOR THIS CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE LABORATO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10550496 ↗
• MalfunctionSep 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMERIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781357203). THIS SAME CUSTOMER HAD PREVIOUSLY NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE OXSF RESULTS WHILE TESTING S. AUREUS WITH AST-GP78 LOT 2781335403 (MDRS 1950204-2020-00154 THROUGH 1950204-2020-00168 WERE SUBMITTED FOR THAT INCIDENT). THE CUSTOMER SWITCHED TO LOT 2781357203 AND NOTICED A DECREASE IN FALSE POSITIVE OXSF RESULTS; HOWEVER, THE DISCREPANT RESULTS STILL OCCURRED. THE CUSTOMER REPORTED OBTAINING THESE DISCREPANT RESULTS WITH FOUR (4) ISOLATES. SUMMARY: ALL PATIENT ISOLATES=S. AUREUS; AST-GP78, LOT 2781357203; INITIAL: OXSF=POSITIVE; REPEAT: NOT PERFORMED; ALTERNATIVE TESTING BY FOX KB AND OX E-TEST CONFIRMED NEGATIVE; NOTE: ABOVE INFORMATION PERTAINS TO ALL FOUR (4) ISOLATES. AN ON-SITE FIELD APPLICATION SPECIALIST (FAS) VISIT FOR TROUBLESHOOTING WAS COMPLETED INCLUDING A REVIEW OF THE CUSTOMER¿S SETUP PROCEDURES. NO OFF-LABEL USE OR USER SETUP ERRORS HAVE BEEN NOTED FOR THIS CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE LABORATOR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10550473 ↗
• MalfunctionSep 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMERIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781357203). THIS SAME CUSTOMER HAD PREVIOUSLY NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE OXSF RESULTS WHILE TESTING S. AUREUS WITH AST-GP78 LOT 2781335403 (MDRS 1950204-2020-00154 THROUGH 1950204-2020-00168 WERE SUBMITTED FOR THAT INCIDENT). THE CUSTOMER SWITCHED TO LOT 2781357203 AND NOTICED A DECREASE IN FALSE POSITIVE OXSF RESULTS; HOWEVER, THE DISCREPANT RESULTS STILL OCCURRED. THE CUSTOMER REPORTED OBTAINING THESE DISCREPANT RESULTS WITH FOUR (4) ISOLATES. SUMMARY: ALL PATIENT ISOLATES=S. AUREUS; AST-GP78, LOT 2781357203; INITIAL: OXSF=POSITIVE; REPEAT: NOT PERFORMED; ALTERNATIVE TESTING BY FOX KB AND OX E-TEST CONFIRMED NEGATIVE; *NOTE: ABOVE INFORMATION PERTAINS TO ALL FOUR (4) ISOLATES. AN ON-SITE FIELD APPLICATION SPECIALIST (FAS) VISIT FOR TROUBLESHOOTING WAS COMPLETED INCLUDING A REVIEW OF THE CUSTOMER¿S SETUP PROCEDURES. NO OFF-LABEL USE OR USER SETUP ERRORS HAVE BEEN NOTED FOR THIS CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE LABORATO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10550457 ↗
• MalfunctionSep 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMERIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781357203). THIS SAME CUSTOMER HAD PREVIOUSLY NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE OXSF RESULTS WHILE TESTING S. AUREUS WITH AST-GP78 LOT 2781335403 (MDRS 1950204-2020-00154 THROUGH 1950204-2020-00168 WERE SUBMITTED FOR THAT INCIDENT). THE CUSTOMER SWITCHED TO LOT 2781357203 AND NOTICED A DECREASE IN FALSE POSITIVE OXSF RESULTS; HOWEVER, THE DISCREPANT RESULTS STILL OCCURRED. THE CUSTOMER REPORTED OBTAINING THESE DISCREPANT RESULTS WITH FOUR (4) ISOLATES. SUMMARY: ALL PATIENT ISOLATES=S. AUREUS; AST-GP78, LOT 2781357203; INITIAL: OXSF=POSITIVE; REPEAT: NOT PERFORMED; ALTERNATIVE TESTING BY FOX KB AND OX E-TEST CONFIRMED NEGATIVE; NOTE: ABOVE INFORMATION PERTAINS TO ALL FOUR (4) ISOLATES. AN ON-SITE FIELD APPLICATION SPECIALIST (FAS) VISIT FOR TROUBLESHOOTING WAS COMPLETED INCLUDING A REVIEW OF THE CUSTOMER¿S SETUP PROCEDURES. NO OFF-LABEL USE OR USER SETUP ERRORS HAVE BEEN NOTED FOR THIS CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE LABORATOR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10550447 ↗
• MalfunctionSep 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMERIEUX REGARDING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR QUALITY CONTROL (QC) STRAIN STAPHYLOCOCCUS AUREUS ATCC® 29213¿ IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781335403). THE FALSE POSITIVE RESULTS WERE OBTAINED DURING REPEAT TESTING. VITEK® 2 OBTAINED FALSE POSITIVE OXSF RESULTS FOR EIGHT (8) OUT OF 21 REPEAT TESTS ON THE QC STRAIN. THE EXPECTED OXSF RESULT WAS SUSCEPTIBLE. GLOBAL CUSTOMER SERVICE (GCS) REVIEWED THE CUSTOMERS TROUBLESHOOTING INFORMATION AND DID NOT IDENTIFY ANY OFF-LABEL USE. 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 COMPLAINT INVESTIGATION IS ACTIVELY UNDERWAY. NO ANOMALIES HAVE BEEN NOTED IN THE MANUFACTURING RECORDS OF AST-GP78 LOT 2781335403. BIOMERIEUX¿S GLOBAL CUSTOMER SERVICE UNIT HAVE CONTACTED THE CUSTOMER WITH REGARDS TO THE INVESTIGATION AND HAVE REQUESTED CASE SPECIFIC CUSTOMER DATA AND THE ASSOCIATED QC ISOLATE TO AID THE INVESTIGATION. A COMPLAINT TREND REVIEW FOR ALL AST LOTS VERSUS FALSE POSITIVE OXSF FOR STAPHYLOCOCCUS AUREUS WAS PERFORMED AND THERE

  Patient problems: No Patient Involvement

  MAUDE report 10480451 ↗
• MalfunctionSep 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX REGARDING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781335403). THE DISCREPANT RESULTS INVOLVED 14 PATIENT ISOLATES AND ONE QC STRAIN (STAPHYLOCOCCUS AUREUS ATCC® 29213¿). VITEK 2 OBTAINED AN OXSF POSITIVE RESULT FOR ALL INITIAL PATIENT TESTING USING LOT 2781335403. THE EXPECTED OXSF RESULT WAS SUSCEPTIBLE FOR EACH ISOLATE. REPEAT TESTING WAS EITHER PERFORMED WITH THE SAME VITEK 2 AST-GP78 CARD LOT, OR BY CEFOXITIN KIRBY BAUER (FOX KB) AND OXACILLIN ETEST® (OX ETEST). RESULTS SUMMARY: PATIENT 5 ((B)(6)), INITIAL (AST-GP78): OXSF POS, OX MIC <=0.25 (R)*, REPEAT (AST-GP78): OXSF NEG, OX MIC <=0.25 (S), ALTERNATIVE: NOT PERFORMED. * DENOTES AN AES (ADVANCED EXPERT SYSTEM¿) THERAPEUTIC CORRECTION FROM SUSCEPTIBLE TO RESISTANT. THERE IS NO INDICATION FROM THE CUSTOMER THAT THIS EVENT IMPACTED THE PATIENTS STATE OF HEALTH OR LED TO A DELAY OF RESULTS. A COMPLAINT INVESTIGATION IS ACTIVELY UNDERWAY. NO ANOMALIES HAVE BEEN NOTED IN THE MANUFACTURING RECORDS OF AST-GP78 LOT 2781335403. BIOMERIEUX¿S GLOBAL CUSTOMER SERVICE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10480443 ↗
• MalfunctionSep 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX REGARDING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781335403). THE DISCREPANT RESULTS INVOLVED 14 PATIENT ISOLATES AND ONE QC STRAIN (STAPHYLOCOCCUS AUREUS ATCC® 29213¿). VITEK 2 OBTAINED AN OXSF POSITIVE RESULT FOR ALL INITIAL PATIENT TESTING USING LOT 2781335403. THE EXPECTED OXSF RESULT WAS SUSCEPTIBLE FOR EACH ISOLATE. REPEAT TESTING WAS EITHER PERFORMED WITH THE SAME VITEK 2 AST-GP78 CARD LOT, OR BY CEFOXITIN KIRBY BAUER (FOX KB) AND OXACILLIN ETEST® (OX ETEST). RESULTS SUMMARY: PATIENT 6 ((B)(6)), INITIAL (AST-GP78): OXSF POS, OX MIC= 0.5 (R)*; REPEAT (AST-GP78): OXSF NEG, OX MIC= 0.5 (S); ALTERNATIVE: NOT PERFORMED. * DENOTES AN AES (ADVANCED EXPERT SYSTEM¿) THERAPEUTIC CORRECTION FROM SUSCEPTIBLE TO RESISTANT. THERE IS NO INDICATION FROM THE CUSTOMER THAT THIS EVENT IMPACTED THE PATIENTS STATE OF HEALTH OR LED TO A DELAY OF RESULTS. A COMPLAINT INVESTIGATION IS ACTIVELY UNDERWAY. NO ANOMALIES HAVE BEEN NOTED IN THE MANUFACTURING RECORDS OF AST-GP78 LOT 2781335403. BIOMERIEUX¿S GLOBAL CUSTOMER SERVICE UNI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10480441 ↗
• MalfunctionSep 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX REGARDING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781335403). THE DISCREPANT RESULTS INVOLVED 14 PATIENT ISOLATES AND ONE QC STRAIN (STAPHYLOCOCCUS AUREUS ATCC® 29213¿). VITEK 2 OBTAINED AN OXSF POSITIVE RESULT FOR ALL INITIAL PATIENT TESTING USING LOT 2781335403. THE EXPECTED OXSF RESULT WAS SUSCEPTIBLE FOR EACH ISOLATE. REPEAT TESTING WAS EITHER PERFORMED WITH THE SAME VITEK 2 AST-GP78 CARD LOT, OR BY CEFOXITIN KIRBY BAUER (FOX KB) AND OXACILLIN ETEST® (OX ETEST). RESULTS SUMMARY: PATIENT 3 ((B)(6)), INITIAL (AST-GP78): OXSF POS, OX MIC <=0.25 (R)*, REPEAT (AST-GP78): NOT PERFORMED ON VITEK® 2, ALTERNATIVE (FOX KB, OX ETEST): SUSCEPTIBLE. DENOTES AN AES (ADVANCED EXPERT SYSTEM¿) THERAPEUTIC CORRECTION FROM SUSCEPTIBLE TO RESISTANT. THERE IS NO INDICATION FROM THE CUSTOMER THAT THIS EVENT IMPACTED THE PATIENTS STATE OF HEALTH OR LED TO A DELAY OF RESULTS. A COMPLAINT INVESTIGATION IS ACTIVELY UNDERWAY. NO ANOMALIES HAVE BEEN NOTED IN THE MANUFACTURING RECORDS OF AST-GP78 LOT 2781335403. BIOMERIEUX¿S GLOBAL CUS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10480438 ↗
• MalfunctionSep 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX REGARDING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781335403). THE DISCREPANT RESULTS INVOLVED 14 PATIENT ISOLATES AND ONE QC STRAIN (STAPHYLOCOCCUS AUREUS ATCC® 29213¿). VITEK 2 OBTAINED AN OXSF POSITIVE RESULT FOR ALL INITIAL PATIENT TESTING USING LOT 2781335403. THE EXPECTED OXSF RESULT WAS SUSCEPTIBLE FOR EACH ISOLATE. REPEAT TESTING WAS EITHER PERFORMED WITH THE SAME VITEK 2 AST-GP78 CARD LOT, OR BY CEFOXITIN KIRBY BAUER (FOX KB) AND OXACILLIN ETEST® (OX ETEST). RESULTS SUMMARY: PATIENT 8 ((B)(6)), INITIAL (AST-GP78): OXSF POS, OX MIC= 0.5 (R)*, REPEAT (AST-GP78): OXSF NEG, OX MIC= 0.5 (S), ALTERNATIVE: NOT PERFORMED. * DENOTES AN AES (ADVANCED EXPERT SYSTEM¿) THERAPEUTIC CORRECTION FROM SUSCEPTIBLE TO RESISTANT. THERE IS NO INDICATION FROM THE CUSTOMER THAT THIS EVENT IMPACTED THE PATIENTS STATE OF HEALTH OR LED TO A DELAY OF RESULTS. A COMPLAINT INVESTIGATION IS ACTIVELY UNDERWAY. NO ANOMALIES HAVE BEEN NOTED IN THE MANUFACTURING RECORDS OF AST-GP78 LOT 2781335403. BIOMERIEUX¿S GLOBAL CUSTOMER SERVICE UNI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10480426 ↗
• MalfunctionSep 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX REGARDING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781335403). THE DISCREPANT RESULTS INVOLVED 14 PATIENT ISOLATES AND ONE QC STRAIN (STAPHYLOCOCCUS AUREUS ATCC® 29213¿). VITEK 2 OBTAINED AN OXSF POSITIVE RESULT FOR ALL INITIAL PATIENT TESTING USING LOT 2781335403. THE EXPECTED OXSF RESULT WAS SUSCEPTIBLE FOR EACH ISOLATE. REPEAT TESTING WAS EITHER PERFORMED WITH THE SAME VITEK 2 AST-GP78 CARD LOT, OR BY CEFOXITIN KIRBY BAUER (FOX KB) AND OXACILLIN ETEST® (OX ETEST). RESULTS SUMMARY: -PATIENT 9 ((B)(6)) INITIAL (AST-GP78): OXSF POS, OX MIC= 0.5 (R)* REPEAT (AST-GP78): OXSF NEG, OX MIC= 0.5 (S), ALTERNATIVE: NOT PERFORMED * DENOTES AN AES (ADVANCED EXPERT SYSTEM¿) THERAPEUTIC CORRECTION FROM SUSCEPTIBLE TO RESISTANT. THERE IS NO INDICATION FROM THE CUSTOMER THAT THIS EVENT IMPACTED THE PATIENTS STATE OF HEALTH OR LED TO A DELAY OF RESULTS. A COMPLAINT INVESTIGATION IS ACTIVELY UNDERWAY. NO ANOMALIES HAVE BEEN NOTED IN THE MANUFACTURING RECORDS OF AST-GP78 LOT 2781335403. BIOMERIEUX¿S GLOBAL CUSTOMER SERVICE UNIT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10480415 ↗
• MalfunctionSep 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX REGARDING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781335403). THE DISCREPANT RESULTS INVOLVED 14 PATIENT ISOLATES AND ONE QC STRAIN (STAPHYLOCOCCUS AUREUS ATCC® 29213¿). VITEK 2 OBTAINED AN OXSF POSITIVE RESULT FOR ALL INITIAL PATIENT TESTING USING LOT 2781335403. THE EXPECTED OXSF RESULT WAS SUSCEPTIBLE FOR EACH ISOLATE. REPEAT TESTING WAS EITHER PERFORMED WITH THE SAME VITEK 2 AST-GP78 CARD LOT, OR BY CEFOXITIN KIRBY BAUER (FOX KB) AND OXACILLIN ETEST® (OX ETEST). RESULTS SUMMARY: PATIENT 7 ((B)(6)), INITIAL (AST-GP78): OXSF POS, OX MIC= 0.5 (R)*; REPEAT (AST-GP78): NOT PERFORMED ON VITEK® 2; ALTERNATIVE (FOX KB, OX ETEST): SUSCEPTIBLE. DENOTES AN AES (ADVANCED EXPERT SYSTEM¿) THERAPEUTIC CORRECTION FROM SUSCEPTIBLE TO RESISTANT. THERE IS NO INDICATION FROM THE CUSTOMER THAT THIS EVENT IMPACTED THE PATIENTS STATE OF HEALTH OR LED TO A DELAY OF RESULTS. A COMPLAINT INVESTIGATION IS ACTIVELY UNDERWAY. NO ANOMALIES HAVE BEEN NOTED IN THE MANUFACTURING RECORDS OF AST-GP78 LOT 2781335403. BIOMERIEUX¿S GLOBAL CUSTO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10480410 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031865, K032766, K050976, K053097, K072668, K072695, K080201, K091126, K122547, K141149, N50510. One submission often covers many models, so check the product and lot details in each record.

• 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