VITEK® 2 GPRecalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 03573026529994), received between May 1, 2017 and Nov 5, 2020 — classified as 2 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (60 reports).

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

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-0788-2023 · Root cause: Storage · FDA record ↗

2. Oct 11, 2017Terminated

   Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with three (3) VITEK(R) 2 GP ID Lots, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. In accordance with the VITEK(R) 2 GP ID Instructions For Use, the expected O129R reaction for ATCC(R) 700327(TM) strain is positive. As a precaution, bioMrieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials.

   Z-0074-2018 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 103 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN GERMANY NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF STAPHYLOCOCCUS HAEMOLYTICUS AS LEUCONONSTOC MESENTEROIDES SSP. CREMORIS IN ASSOCIATION WITH THE VITEK® 2 GP ID TEST KIT (REF 21342, LOT 2421450403) AND THEIR VITEK® 2 COMPACT 30 [U] (REF 27530U, SERIAL VK2C18637). TROUBLESHOOTING BY LOCAL CUSTOMER SERVICE (LCS) IDENTIFIED THAT THERE WAS NO INDICATION OF OFF-LABEL USE OR USER ERROR WITH RESPECT TO CULTURING THE ORGANISM PRIOR TO ANALYZING THEM WITH THE GP ID TEST KIT. DUE TO THE TYPE OF ISSUE BEING OBSERVED BY THE CUSTOMER, LCS SUSPECTED THE CUSTOMER'S INSTRUMENT MAY BE THE SOURCE OF THE PROBLEM AND LCS IDENTIFIED THAT THE CUSTOMER'S INSTRUMENT WAS OVERDUE FOR PREVENTIVE MAINTENANCE (PM). THE PREVIOUS PM WAS COMPLETED IN MAY 2019. IT IS RECOMMENDED THAT THIS PM IS PERFORMED AT LEAST ANNUALLY. THE CUSTOMER WAS INSTRUCTED BY LCS TO USE ALTERNATE TEST METHODS FOR IDENTIFICATION AND AST TESTING UNTIL A PM COULD BE COMPLETED. A PM WAS PERFORMED ON 20OCT2020 BY A FIELD SERVICE ENGINEER (FSE) AND THEN THE ISOLATE WAS RETESTED. THE CUSTOMER REPORTED THAT THERE WERE NO ISSUES WITH THE RESULTS OBTAINED AFTER THE PM WAS COMPLETED. ISOLATE 10054568 INITIAL TEST = LEUC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10792457 ↗
• MalfunctionApr 29, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN COLOMBIA NOTIFIED BIOMERIEUX OF A MISIDENTIFICATION OF STAPHYLOCOCCUS HAEMOLYTICUS AS STAPHYLOCOCCUS LENTUS IN ASSOCIATION WITH THE VITEK® 2 GRAM POSITIVE (GP) IDENTIFICATION (ID) TEST KIT (REF. 21342, LOT 2421301203). IN RESPONSE TO THE CUSTOMER COMPLAINT, A BIOMÉRIEUX FIELD APPLICATION SPECIALIST (FAS) VISITED THE CUSTOMER SITE AND CONFIRMED THE FOLLOWING: RECOMMENDATIONS FOR ISOLATE PREPARATION AND SETUP. THE SALINE SOLUTION IS STERILE. THE BRINKMANN DISPENSETTE IS STERILIZED EVERY OTHER DAY. BIOMÉRIEUX MEDIA ARE USED FOR ORGANISM GROWTH. THE VITEK 2 SYSTEMS SOFTWARE WAS UPDATED TO VERSION 9.02. THE STRAINS ARE PURE AND ISOLATED. THEREFORE, THE CUSTOMER AND FAS CONSIDER THAT ANY ISSUES WITH THE PRE-ANALYTICAL PHASE AS A ROOT CAUSE HAVE BEEN RULED OUT. A NEW VITEK® 2 COMPACT WAS INSTALLED AT THE CUSTOMER SITE; HOWEVER, THE ISSUES WERE NOT RESOLVED. ELECTRICAL TESTS AT THE CUSTOMER SITE WILL BE CONDUCTED IN ORDER TO TEST ELECTRICAL DISCREPANCIES. 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 10009545 ↗
• MalfunctionApr 28, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOM¿RIEUX OF A MISIDENTIFICATION OF STAPHYLOCOCCUS HAEMOLYTICUS AS STAPHYLOCOCCUS LENTUS IN ASSOCIATION WITH THE VITEK¿ 2 GRAM POSITIVE (GP) IDENTIFICATION (ID) TEST KIT (REF. 21342, LOT 2421287103). IN RESPONSE TO THE CUSTOMER COMPLAINT, A BIOM¿RIEUX FIELD APPLICATION SPECIALIST (FAS) VISITED THE CUSTOMER SITE AND CONFIRMED THE FOLLOWING: RECOMMENDATIONS FOR ISOLATE PREPARATION AND SETUP. THE SALINE SOLUTION IS STERILE. THE BRINKMANN DISPENSETTE IS STERILIZED EVERY OTHER DAY. BIOM¿RIEUX MEDIA ARE USED FOR ORGANISM GROWTH. THE VITEK 2 SYSTEMS SOFTWARE WAS UPDATED TO (B)(4). THE STRAINS ARE PURE AND ISOLATED. THEREFORE, THE CUSTOMER AND FAS CONSIDER THAT ANY ISSUES WITH THE PRE-ANALYTICAL PHASE AS A ROOT CAUSE HAVE BEEN RULED OUT. A NEW VITEK¿ 2 COMPACT WAS INSTALLED AT THE CUSTOMER SITE; HOWEVER, THE ISSUES WERE NOT RESOLVED. ELECTRICAL TESTS AT THE CUSTOMER SITE WILL BE CONDUCTED IN ORDER TO TEST ELECTRICAL DISCREPANCIES. 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. A BIOM¿RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10006496 ↗
• InjuryOct 4, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF STAPHYLOCOCCUS HAEMOLYTICUS AS STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH THE VITEK® 2 GRAM POSITIVE (GP) IDENTIFICATION (ID) TEST KIT (REF. 21342, LOT 2421088403). THE SUSCEPTIBILITY TESTING WAS PERFORMED USING THE ORGANISM ID OF STAPHYLOCOCCUS AUREUS, AND THE STRAIN WAS FURTHER IDENTIFIED AS (B)(6). THE PATIENT WAS ISOLATED AND TREATED AGAINST STAPHYLOCOCCUS AUREUS (VANCOMYCIN + AMIKACIN). VITEK 2 GP ID = STAPHYLOCOCCUS AUREUS. NATIONAL LABORATORY FOR STUDY (REFERENCE LAB) = STAPHYLOCOCCUS HAEMOLYTICUS (TESTING METHOD NOT DISCLOSED BY THE CUSTOMER). FOLLOWING RECEIPT OF THE REFERENCE LAB RESULT, RETESTING VIA VITEK® MS AND VITEK® 2 GP ID OBTAINED ORGANISM IDENTIFICATIONS TO STAPHYLOCOCCUS HAEMOLYTICUS. THE CUSTOMER STATED THERE WAS A "DELAY OF 48 HOURS". THE CUSTOMER ALSO STATED "THE PATIENT WAS TREATED INCORRECTLY" [I.E. FOR STAPHYLOCOCCUS AUREUS (B)(6) RATHER THAN STAPHYLOCOCCUS HAEMOLYTICUS]. THOUGH MULTIPLE ATTEMPTS HAVE BEEN MADE BY BIOMÉRIEUX TO OBTAIN INFORMATION REGARDING THE PATIENTS HEALTH, THERE HAVE BEEN NO STATEMENT(S) FROM THE LABORATORY OR THE TREATING PHYSICIAN REGARDING TREATMENT EFFECTIVENESS, ADD

  Patient problems: Misdiagnosis

  MAUDE report 9156792 ↗
• MalfunctionOct 29, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF STAPHYLOCOCCUS LUGDUNENSIS AS LEUCONOSTOC MESENTEROIDES FOR TWO PATIENT ISOLATES WITH THE VITEK® 2 GP ID TEST KIT. ON (B)(6) 2018, THE GP CARD IDENTIFIED LEUCONOSTOC MESENTEROIDES AND THE ISOLATES WERE CONFIRMED AS STAPHYLOCOCCUS LUGDUNENSIS BY MALDI-TOF. THE CUSTOMER REPORTED THAT THE VITEK RESULT WAS NOT REPORTED TO A PHYSICIAN AND PATIENT CARE WAS NOT IMPACTED. THE LOCAL FIELD APPLICATION SPECIALIST (FAS) WENT TO THE SITE AND RETESTED THE ISOLATES AND THE IDENTIFICATION WAS STAPHYLOCOCCUS LENTUS (99%). THE FAS THEN TESTED A FRESH ISOLATE AT A DIFFERENT CUSTOMER SITE AND THE IDENTIFICATION WAS STAPHYLOCOCCUS LUGDONENSIS (99%). THE CUSTOMER PERFORMED REPEAT TESTING ON THE TWO ISOLATES ON THEIR THREE VITEK INSTRUMENTS. ISOLATE (B)(4) WAS IDENTIFIED AS STAPHYLOCOCCUS LENTUS ON ALL THREE INSTRUMENTS. ISOLATE (B)(4) HAD ONE IDENTIFICATION AS STAPHYLOCOCCUS LENTUS AND TWO AS STAPHYLOCOCCUS LUGDONENSIS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8017119 ↗
• MalfunctionOct 29, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF STAPHYLOCOCCUS LUGDUNENSIS AS LEUCONOSTOC MESENTEROIDES FOR TWO PATIENT ISOLATES WITH THE VITEK® 2 GP ID TEST KIT. ON (B)(6) 2018, THE GP CARD IDENTIFIED LEUCONOSTOC MESENTEROIDES AND THE ISOLATES WERE CONFIRMED AS STAPHYLOCOCCUS LUGDUNENSIS BY MALDI-TOF. THE CUSTOMER REPORTED THAT THE VITEK RESULT WAS NOT REPORTED TO A PHYSICIAN AND PATIENT CARE WAS NOT IMPACTED. THE LOCAL FIELD APPLICATION SPECIALIST (FAS) WENT TO THE SITE AND RETESTED THE ISOLATES AND THE IDENTIFICATION WAS STAPHYLOCOCCUS LENTUS (99%). THE FAS THEN TESTED A FRESH ISOLATE AT A DIFFERENT CUSTOMER SITE AND THE IDENTIFICATION WAS STAPHYLOCOCCUS LUGDONENSIS (99%). THE CUSTOMER PERFORMED REPEAT TESTING ON THE TWO ISOLATES ON THEIR THREE VITEK INSTRUMENTS. ISOLATE (B)(4)WAS IDENTIFIED AS STAPHYLOCOCCUS LENTUS ON ALL THREE INSTRUMENTS. ISOLATE (B)(4) HAD ONE IDENTIFICATION AS STAPHYLOCOCCUS LENTUS AND TWO AS STAPHYLOCOCCUS LUGDONENSIS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8017117 ↗
• MalfunctionOct 15, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF A MISIDENTIFICATION OF CAP SURVEY ENTEROCOCCUS FAECIUM ((B)(4)) AS ENTEROCOCCUS GALLINARUM IN ASSOCIATION WITH THE VITEK® 2 GRAM POSITIVE (GP) IDENTIFICATION (ID) TEST KIT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR A PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE CAP SURVEY STRAIN. BIOMÉRIEUX REQUESTED STRAIN SUBMITTAL FROM THE CUSTOMER; HOWEVER, THE STRAIN IS NO LONGER AVAILABLE. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED AND WILL USE BIOMÉRIEUX'S INTERNAL CAP SURVEY STRAIN.

  Patient problems: No Patient Involvement

  MAUDE report 7966951 ↗
• MalfunctionOct 11, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS BETWEEN THE VITEK® 2 GP ID CARD (REF 21342) AND THE VITEK® MS INSTRUMENT. THE CUSTOMER REPORTED AN ISOLATE FROM A BLOOD CULTURE WAS IDENTIFIED BY A LATEX AGGLUTINATION TEST AS STAPHYLOCOCCUS AUREUS AND THE SUSCEPTIBILITY YIELDED A VANCOMYCIN OF 4UG/ML. ETEST® WAS PERFORMED TO CONFIRM. THE ISOLATE WAS SUBMITTED TO A REFERENCE LAB FOR ORITAVANCIN TESTING, AND WAS IDENTIFIED AS A POSSIBLE S. COHNII, SO THE CUSTOMER REEVALUATED THE BLOOD CULTURE AND DETERMINED THE PRESENCE OF THREE (3) MORPHOLOGICALLY DIFFERENT ISOLATES. THE THREE (3) ISOLATES WERE IDENTIFIED AS STAPHYLOCOCCUS AUREUS WITH THE VITEK MS ON (B)(6) 2018 IN ADDITION TO VITEK 2 TESTING IN WHICH THE RESULTS DID NOT MATCH. TUBE COAGULATION APPEARED TO BE POSITIVE FOR ALL ISOLATES. THE FINAL IDENTIFICATION FROM THE REFERENCE LAB WAS S. LUGDUNENSIS, WHICH LED THE CUSTOMER TO INITIALLY REPORT THAT THE VITEK MS LED TO THE MISIDENTIFICATION. HOWEVER, THE ISOLATES WERE SUBMITTED FOR INTERNAL INVESTIGATION BY BIOMÉRIEUX. THE INVESTIGATION INCLUDED 16S SEQUENCING OF THE ISOLATES, WHICH GAVE AN IDENTIFICATION TO STAPHYLOCOCCUS AUREUS. ACCORDING TO R&D, A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7958244 ↗
• MalfunctionOct 9, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS STAPHYLOCOCCUS PSEUDINTERMEDIUS IN ASSOCIATION WITH THE VITEK® 2 GP (GRAM-POSITIVE) ID TEST KIT (LOT 2420686403). THE CUSTOMER REPORTED THAT THE GP ID CARD IDENTIFIED S. PSEUDINTERMEDIUS AND BOTH VITEK MS AND API® IDENTIFIED S. AUREUS. THE TEST WAS REPEATED ON TWO VITEK 2 INSTRUMENTS AND THE RESULTS WERE S. PSEUDINTERMEDIUS. BOTH INSTRUMENTS WERE RECENTLY SERVICED AND PASSED QC. THE CUSTOMER STATED THE PATIENT RESULT WAS NOT AFFECTED AND THERE WAS A 24 HOUR DELAY DUE TO REPEAT TESTING. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7949735 ↗
• MalfunctionOct 3, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF A LISTERIA MONOCYTOGENES STRAIN IN ASSOCIATION WITH THE VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) CARD. THE CUSTOMER DID NOT PROVIDE THE ORGANISM SPECIES TO WHICH THE GP ID CARD MADE THE IDENTIFICATION, NOR PROVIDE INFORMATION REGARDING ANY ALTERNATE METHOD USED TO OBTAIN THE CORRECT IDENTIFICATION OF LISTERIA MONOCYTOGENES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX REQUESTED STRAIN SUBMITTAL FROM THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7932468 ↗
• MalfunctionSep 24, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A VETERINARY CUSTOMER FROM THE (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION RESULT FOR STREPTOCOCCUS EQUI SSP ZOOEPIDEMICUS ATCC STRAIN 700400 WHEN TESTING WITH THE VITEK® 2 GP ID TEST KIT (REF (B)(4), LOT 2420595103). THE VITEK 2 GP ID CARD OBTAINED AN IDENTIFICATION OF STREPTOCOCCUS CANIS. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7903666 ↗
• MalfunctionSep 24, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A VETERINARY CUSTOMER FROM THE (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION RESULT FOR STREPTOCOCCUS EQUI SSP ZOOEPIDEMICUS ATCC STRAIN 700400 WHEN TESTING WITH THE VITEK® 2 GP ID TEST KIT (REF 21342, LOT 2420640403). THE VITEK 2 GP ID CARD OBTAINED AN IDENTIFICATION OF STREPTOCOCCUS CANIS. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7903663 ↗
• MalfunctionSep 18, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) REPORTED A MISIDENTIFICATION OF ACTINOMYCES ISRAELII AS GARDNERELLA VAGINALIS IN ASSOCIATION WITH THE VITEK® 2 GP ID TEST KIT. THE CUSTOMER STATED THEY CULTURED A GRAM-POSITIVE ROD FROM PLEURAL FLUID WHICH WAS IDENTIFIED WITH VITEK 2 GP ID CARD AS GARDNELLA VAGINALIS. THE ISOLATE WAS TESTED MULTIPLE TIMES ON VITEK MS AND THE RESULTS WERE NO IDENTIFICATION. THE SAMPLE WAS SENT TO THE PUBLIC HEALTH ENGLAND AT COLINDALE WHO IDENTIFIED THE ISOLATE AS ACTINOMYCES ISRAELII BY PARTIAL SEQUENCING OF THE 16S RRNA GENE. THE CUSTOMER REPORTED THAT THE PATIENT WAS GIVEN INAPPROPRIATE ANTIMICROBIAL TREATMENT PRIOR TO THE CORRECT IDENTIFICATION OF ACTINOMYCES ISRAELII, WHICH WAS OBTAINED 10 DAYS LATER FROM THE REFERENCE LAB. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: Misdiagnosis; No Known Impact Or Consequence To Patient

  MAUDE report 7885777 ↗
• MalfunctionAug 31, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED MISIDENTIFICATIONS OF STREPTOCOCCUS SPECIES FOR FOUR (4) PATIENT ISOLATES IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT (LOT 2420749203). THE CUSTOMER REPORTED THAT ALL FOUR ISOLATES WERE FROM SMALL BOWEL BRUSHINGS AND THE CULTURES WERE PURE ALPHA HEMOLYTIC ISOLATES. (B)(6). NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7837134 ↗
• MalfunctionAug 31, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED MISIDENTIFICATIONS OF STREPTOCOCCUS SPECIES FOR FOUR (4) PATIENT ISOLATES IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT (LOT 2420749203). THE CUSTOMER REPORTED THAT ALL FOUR ISOLATES WERE FROM SMALL BOWEL BRUSHINGS AND THE CULTURES WERE PURE ALPHA HEMOLYTIC ISOLATES. ISOLATE 1819805109: VITEK 2 GP: STREPTOCOCCUS PSEUDOPORCINUS (95%); REPEAT: UNIDENTIFIED ORGANISM REFERENCE LAB (B)(4): STREPTOCOCCUS MITIS/ORALIS ISOLATE 1820406366: VITEK 2 GP: LOW DISCRIMINATION STREPTOCOCCUS MITIS/ORALIS; REPEAT 1: LOW DISCRIMINATION STREPTOCOCCUS PSEUDOPORCINUS; REPEAT 2: LOW DISCRIMINATION GRANULICATELLA ADIACENS REFERENCE LAB (B)(4): STREPTOCOCCUS MITIS/ORALIS ISOLATE 1819208351: VITEK 2 GP: STREPTOCOCCUS THORALTENSIS; REPEAT: STREPTOCOCCUS MITIS/ORALIS. ISOLATE 1818304053: VITEK 2 GP: STREPTOCOCCUS PSEUDOPORCINUS; REPEAT: STREPTOCOCCUS MITIS/ORALIS. NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7837132 ↗
• MalfunctionAug 31, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED MISIDENTIFICATIONS OF STREPTOCOCCUS SPECIES FOR FOUR (4) PATIENT ISOLATES IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT (LOT 2420749203). THE CUSTOMER REPORTED THAT ALL FOUR ISOLATES WERE FROM SMALL BOWEL BRUSHINGS AND THE CULTURES WERE PURE ALPHA HEMOLYTIC ISOLATES. ISOLATE 1819805109: VITEK 2 GP: STREPTOCOCCUS PSEUDOPORCINUS (95%); REPEAT: UNIDENTIFIED ORGANISM REFERENCE LAB (B)(4) (B)(4): STREPTOCOCCUS MITIS/ORALIS ISOLATE 1820406366: VITEK 2 GP: LOW DISCRIMINATION STREPTOCOCCUS MITIS/ORALIS; REPEAT 1: LOW DISCRIMINATION STREPTOCOCCUS PSEUDOPORCINUS; REPEAT 2: LOW DISCRIMINATION GRANULICATELLA ADIACENS REFERENCE LAB (B)(4): STREPTOCOCCUS MITIS/ORALIS ISOLATE 1819208351: VITEK 2 GP: STREPTOCOCCUS THORALTENSIS; REPEAT: STREPTOCOCCUS MITIS/ORALIS. ISOLATE 1818304053: VITEK 2 GP: STREPTOCOCCUS PSEUDOPORCINUS; REPEAT: STREPTOCOCCUS MITIS/ORALIS. NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7837128 ↗
• MalfunctionAug 31, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED MISIDENTIFICATIONS OF STREPTOCOCCUS SPECIES FOR FOUR (4) PATIENT ISOLATES IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT (LOT 2420749203). THE CUSTOMER REPORTED THAT ALL FOUR ISOLATES WERE FROM SMALL BOWEL BRUSHINGS AND THE CULTURES WERE PURE ALPHA HEMOLYTIC ISOLATES. ISOLATE (B)(4): VITEK 2 GP: STREPTOCOCCUS PSEUDOPORCINUS (95%); REPEAT: UNIDENTIFIED ORGANISM REFERENCE LAB MALDI TOF: STREPTOCOCCUS MITIS/ORALIS ISOLATE (B)(4): VITEK 2 GP: LOW DISCRIMINATION STREPTOCOCCUS MITIS/ORALIS; REPEAT 1: LOW DISCRIMINATION STREPTOCOCCUS PSEUDOPORCINUS; REPEAT 2: LOW DISCRIMINATION GRANULICATELLA ADIACENS REFERENCE LAB MALDI TOF: STREPTOCOCCUS MITIS/ORALIS ISOLATE (B)(4): VITEK 2 GP: STREPTOCOCCUS THORALTENSIS; REPEAT: STREPTOCOCCUS MITIS/ORALIS ISOLATE (B)(4): VITEK 2 GP: STREPTOCOCCUS PSEUDOPORCINUS; REPEAT: STREPTOCOCCUS MITIS/ORALIS NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7837125 ↗
• MalfunctionAug 29, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED IDENTIFICATION ISSUES IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT (LOT 2420689403). THE CUSTOMER REPORTED THAT THE GP CARD DID NOT IDENTIFY MULTIPLE ORGANISMS CORRECTLY AND THAT REPEAT TESTS WERE EITHER THE SAME IDENTIFICATION OR LOW DISCRIMINATION. FOR ISOLATE (B)(4), BOTH THE INITIAL AND REPEAT TEST RESULTS WERE STREPTOCOCCUS PSEUDOPORCINUS. THE CUSTOMER STATED THAT ISOLATE (B)(4) IS AN ALPHA STREP. THE CUSTOMER DID NOT PROVIDE THE EXPECTED IDENTIFICATION OF THE ISOLATE. THE CUSTOMER REPORTED THAT NO INCORRECT TREATMENT OR HARM TO THE PATIENT OCCURRED; HOWEVER, THE RESULTS WERE DELAYED GREATER THAN 24 HOURS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7831274 ↗
• MalfunctionAug 28, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS WHEN TESTING A STREPTOCOCCUS EQUI SSP ZOOEPIDEMICUS ISOLATE OBTAINED FROM AN EQUINE NASAL SWAB. THE TESTING AND RESULTS WERE AS FOLLOWS: VITEK 2 RESULT : STREPTOCOCCUS EQUI SSP EQUI. API RESULT - STREPTOCOCCUS EQUI SSP ZOOEPIDEMICUS. PCR RESULT - STREPTOCOCCUS EQUI SSP ZOOEPIDEMICUS. THE CUSTOMER REPORTED THAT NO RESULTS WERE AFFECTED, NO WRONG RESULT WAS REPORTED, AND NO ANIMAL WAS HARMED OR TREATED INCORRECTLY. THE RESULTS WERE DELAYED BY FOUR DAYS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7824958 ↗
• MalfunctionAug 28, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED IDENTIFICATION ISSUES IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT (LOT TO 2420749203). THE CUSTOMER REPORTED THAT THE GP CARD DID NOT IDENTIFY MULTIPLE ORGANISMS CORRECTLY, ESPECIALLY VIRIDANS STREPTOCOCCI. THE CUSTOMER STATED REPEAT TESTS WERE EITHER THE SAME IDENTIFICATION OR LOW DISCRIMINATION. FOR ISOLATE 201303-1, BOTH THE INITIAL AND REPEAT TEST RESULTS WERE STREPTOCOCCUS PSEUDOPORCINUS. THE CUSTOMER STATED THAT ISOLATE 201303-1 IS AN ALPHA STREP. THE CUSTOMER DID NOT PROVIDE THE EXPECTED IDENTIFICATION OF THE ISOLATE. NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7824232 ↗
• MalfunctionAug 8, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION RESULT WHEN TESTING AN ATCC STAPHYLOCOCCUS PNEUMOCOCCUS STRAIN (ATCC 46619) WITH THE VITEK® 2 GP ID TEST KIT (REF 21342). VITEK 2 IDENTIFIED THE STRAIN AS STAPHYLOCOCCUS SALIVARIUS SSP SALIVARIUS. THIS RESULT WAS OBTAINED WHEN TESTING THE STRAIN IN PATIENT MODE RATHER THAN QC MODE. THE STRAIN WAS ALSO CONFIRMED AS STREPTOCOCCUS PNEUMONIAE VIA VITEK MS. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7764477 ↗
• MalfunctionJul 19, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS WHEN TESTING WITH THE VITEK® 2 GP ID TEST KIT. VITEK 2 OBTAINED AN IDENTIFICATION OF (B)(6). THREE ANALYSTS AT THE CUSTOMER SITE CONFIRMED THAT THE ISOLATE WAS COAGULASE (B)(6). THEREFORE, THE CUSTOMER STATED THAT THE ISOLATE WOULD NOT BE (B)(6). THE CUSTOMER IS A PHARMACEUTICAL COMPANY, AND THEY HAVE STATED THAT THERE IS NO PATIENT ASSOCIATED WITH THE TESTED ISOLATE. AS THERE IS NO PATIENT ASSOCIATED WITH THIS STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7703107 ↗
• MalfunctionJul 17, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF A MISIDENTIFICATION ASSOCIATED WITH VITEK® GP TEST KIT (REFERENCE 21342). THE CUSTOMER REPORTED OBSERVING AN INCORRECT IDENTIFICATION OF GLOBICATELLA SANGUINIS FOR AN ACTINOTIGNUM SCHAALII EEQ CTCB SURVEY STRAIN. THE STRAIN WAS TESTED ON THREE (3) DIFFERENT AGAR PLATES: CNA (PRESENCE OF COLONIES), CHOCOLATE (PRESENCE OF COLONIES), CPS (ABSENCE OF COLONIES). THE CUSTOMER REPORTED NOT PERFORMING ROUTINE QUALITY CONTROL CHECKS. A GRAM STAIN WAS PERFORMED PRIOR TO CARD SET UP AND FOUND GRAM-POSITIVE COCCI AND CATALASE NEGATIVE. AS INDICATED IN THE CTCB SURVEY INSTRUCTIONS ACTINOTIGNUM SCHAALII IS A "SHORT BACILLUS, ALMOST COCCI-LIKE" WHICH COULD EXPLAIN THE "COCCI GRAM +" RESULT AND CONSEQUENTLY THE CHOICE OF THE GP ID CARD. THIS ORGANISM SHOULD BE TESTED WITH THE VITEK 2 ANC TEST KIT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE EEQ SURVEY STRAIN. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7694062 ↗
• MalfunctionJul 11, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK®2 GP TEST KIT (REFERENCE 21342). THE CUSTOMER REPORTED HAVING A PATIENT WITH BLOOD CULTURE ISOLATE THAT IDENTIFIED TWICE AS PEDIOCOCCUS. THE ISOLATE WAS SENT OUT TO A REFERENCE LABORATORY AND THE IDENTIFICATION FOR THE ISOLATE IS STREPTOCOCCUS SANGUINIS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679674 ↗
• MalfunctionJul 10, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES REPORTED A MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS PATIENT STRAIN (WOUND CULTURE) AS STAPHYLOCOCCUS PSEUDINTERMEDIUS IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT (LOT 2420614403). THE CUSTOMER OBTAINED THE IDENTIFICATION OF S. PSEUDINTERMEDIUS USING THE GP CARD AND THEIR LATEX TEST WAS POSITIVE. ALTERNATE TESTING WAS DONE BY AN EXTERNAL LAB THAT TESTED THE STRAIN BY VITEK 2, VITEK MS, AND MICROSCAN IN WHICH ALL METHODS IDENTIFIED THE ORGANISM AS S.AUREUS. THE CUSTOMER REPORTED THAT TO THEIR KNOWLEDGE THERE WAS NO DELAY, THERE WAS NO UNNECESSARY PATIENT TREATMENT OR PROCEDURES AND NO NOTIFICATION FROM A PHYSICIAN ABOUT THE RESULT(S). 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7675818 ↗