VITEK® 2 NHRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03573026529710), received between Jul 17, 2017 and Feb 5, 2021 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (10 reports).

1 FDA recall record 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-0791-2023 · Root cause: Storage · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF THE MISIDENTIFICATION OF A PATIENT CAMPYLOBACTER FETUS ISOLATE AS CAMPYLOBACTER COLI IN ASSOCIATION WITH THE VITEK® 2 NH-ID TEST KIT (REF. (B)(4), LOT 2451162203). THE PATIENT ISOLATE SOURCED FROM AN AORTIC PROSTHESIS WAS SUBCULTURED ONTO CHOCOLATE AGAR THEN TESTED USING LOT 2451162203. LOT 2451162203 IDENTIFIED THE ISOLATE AS CAMPYLOBACTER COLI. THE CUSTOMER ALSO SENT THE PATIENT ISOLATE TO ANOTHER LABORATORY FOR CONFIRMATORY TESTING USING THE MALDI-TOF TEST METHOD; AN IDENTIFICATION OF CAMPYLOBACTER FETUS WAS OBTAINED. REVIEW OF THE CUSTOMER¿S LAB REPORTS SHOWED AN INCREASED NUMBER OF ATYPICAL WELL REACTIONS THAT CAN INDICATE USE OF NON-RECOMMENDED MEDIA. BIOMERIEUX CUSTOMER SERVICE ADVISED THE CUSTOMER THAT USE OF CHOCOLATE AGAR IS NOT RECOMMENDED FOR TESTING OF CAMPYLOBACTER WITH THE VITEK® 2 NH-ID TEST KIT. THE VITEK® 2 NH-ID TEST KIT INSTRUCTIONS FOR USE(IFU) "CULTURE REQUIREMENTS TABLE" STATES THE FOLLOWING AGAR TYPES ARE VALIDATED FOR CULTURING CAMPYLOBACTER: TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD, COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD, COLUMBIA HORSE BLOOD AGAR, AND TRYPTICASE SOY AGAR WITH 5% HORSE BLOOD. THE IFU ALSO STATES

  Patient problems: Misdiagnosis

  MAUDE report 11288666 ↗
• MalfunctionSep 13, 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 FOR A CAP SURVEY STRAIN WHEN TESTING WITH VITEK® 2 NH ID TEST KIT. THE EXPECTED IDENTIFICATION IS ACINETOBACTER LWOFFI, ACINETOBACTER JUNII (LWOFFI/JOHNSONII), OR ACINETOBACTER SP. WHEN TESTING THIS STRAIN WITH THE NH ID CARD, THE STRAIN WAS IDENTIFIED AS MORAXELLA (BRANHAMELLA) CATARRHALIS. 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 7875081 ↗
• MalfunctionSep 12, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED A MISIDENTIFICATION OF AN ACINETOBACTER LWOFFII CAP SURVEY SAMPLE (SPUTUM), AS MORAXELLA CATARRHALIS (92%) IN ASSOCIATION WITH THE VITEK® 2 NH TEST KIT. THE NH CARD RESULT HAD LOW DISCRIMINATION MORAXELLA CATARRHALIS/CAMPYLOBACTER COLI WITH CONTRAINDICATING BIOPATTERNS, SO THE CUSTOMER TESTED THE ISOLATE ON THE VITEK GN CARD AND OBTAINED THE RESULT OF MORAXELLA GROUP. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7870611 ↗
• MalfunctionAug 20, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) REPORTED A MISIDENTIFICATION OF (B)(6) QUALITY CONTROL SAMPLES AS MORAXELLA CATARRHALIS, WHEN USING THE VITEK® 2 NH TEST KIT (LOT 2450570403). THE CUSTOMER TESTED FOUR ISOLATES PROVIDED BY A REFERENCE LAB ((B)(6)) IN WHICH IDENTIFICATION WAS ESTABLISHED AS (B)(6). THE RESULTS ON THE FOUR STRAINS WERE: (B)(6). THE CUSTOMER CONFIRMED THE IDENTIFICATION OF (B)(6) WITH THE MALDI METHOD. THE CUSTOMER TESTED THE LOT WITH THE (B)(6), WHICH GAVE AN ACCEPTABLE RESULT. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO A QC SAMPLE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7798293 ↗
• MalfunctionAug 10, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF A MISIDENTIFICATION OF CAMPYLOBACTER SPECIES AS NEISSERIA CINEREA IN ASSOCIATION WITH THE VITEK® 2 NEISSERIA-HAEMOPHILUS (NH) IDENTIFICATION (ID) TEST KIT. THE CUSTOMER DID NOT INDICATE IF REPEAT OR CONFIRMATORY TESTING WAS PERFORMED. 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 7774033 ↗
• MalfunctionMay 24, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION ASSOCIATED WITH VITEK®2 NH TEST KIT (REFERENCE (B)(4)). THE CUSTOMER REPORTED WHILE TESTING A STRAIN ON THE NH CARD THEY OBTAINED A LOW DISCRIMINATION BETWEEN ACTINOBACILLUS UREA AND H. INFLUENZA SPECIES. A SUBCULTURE WAS PERFORMED AND SET TO THE HOSPITAL FOR IDENTIFICATION VIA SPECTROMETRY, AND THE RESULT WAS NEISSERIA MENINGITIDES. RESULTS FROM THE HOSPITAL WERE OBTAINED FOUR (4) DAYS AFTER THE FIRST TEST. THERE IS NO KNOWN IMPACT TO THE PATIENT, HOWEVER THERE WAS A DELAY IN REPORTING RESULTS OF FOUR (4) DAYS. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7540800 ↗
• MalfunctionMar 20, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN THE UNITED STATES REPORTED A MISIDENTIFICATION OF (B)(6) AS NEISSERIA MENINGITIDES IN ASSOCIATION WITH THE VITEK® 2 NH TEST KIT. THE CUSTOMER STATED THE INITIAL IDENTIFICATION OF N. MENINGITIDES WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN REQUESTED THAT THE ISOLATE BE RETESTED AS THEY BELIEVED IT TO BE (B)(6), AND THE PATIENT WAS BEING TREATED FOR IT. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE NH CARD FROM THE ORIGINAL PLATE, AS THERE WAS NOT ENOUGH GROWTH FOR THE REQUIRED MCFARLAND RANGE. A LOW DISCRIMINATION RESULT WAS RECEIVED, WHICH DID NOT INCLUDE (B)(6). THE ISOLATE WAS SENT OUT TO A REFERENCE LAB WHICH REPORTED THAT THE ISOLATE WAS DEAD AND NO IDENTIFICATION COULD BE MADE. THE CUSTOMER STATED THE ISOLATE IS NO LONGER AVAILABLE. 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 7355105 ↗
• MalfunctionMar 9, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK®2 NH ID TEST KIT (REFERENCE 21346) LOT 2450221203. THE CUSTOMER WAS TESTING AN RCPA-QAP SURVEY SAMPLE (8-2017) IDENTIFIED AS AGGREGATIBACTER APHROPHILUS, AND VITEK 2 IDENTIFIED IT AS ACTINOBACILLUS PLEUROPNEUMONIAE. THE CUSTOMER TESTED THE SAMPLE MULTIPLE TIMES WITH THE FOLLOWING RESULTS: (B)(6). THE SAMPLE USED WAS FOR QUALITY ASSURANCE TESTING. THERE WAS NO EFFECT ON ANY PATIENT TREATMENT OR CONDITION. 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. VITEK 2 NH ID TEST KIT, LOT 2450221203 WAS INCLUDED IN FSCA 3445. PER THE CUSTOMER, THERE WAS NO DEFECT FOUND UPON INSPECTION. AS STATED IN FSCA 3445, CARDS WITH INTACT INTEGRITY CAN BE USED. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE CONDUCTED.

  Patient problems: No Patient Involvement

  MAUDE report 7327526 ↗
• MalfunctionSep 15, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED VITEK® 2 NH TEST KIT (REFERENCE 21346). THE CUSTOMER REPORTED THAT THE VITEK® 2 IDENTIFIED THE STRAIN AS NEISSERIA CINEREA (94% PROBABILITY) INSTEAD OF CAMPYLOBACTER COLI (RESULT BY A VITEK® MS 99.9% PROBABILITY). 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 6867918 ↗
• MalfunctionSep 14, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION RESULT FOR AN ATCC CAMPYLOBACTER FETUS STRAIN WHEN USING VITEK® 2 NH ID TEST KIT (REF 21346), LOT 245385020. VITEK® 2 IDENTIFIED THE STRAIN AS CAMPYLOBACTER COLI TWICE. THE CUSTOMER RETESTED THIS ATCC STRAIN WITH THE MALDI-TOF METHOD AND OBTAINED CAMYLOBACTER FETUS. 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. THERE WAS NO PATIENT ASSOCIATED WITH THIS ATCC QUALITY STRAIN. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 6866880 ↗
• MalfunctionSep 1, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF NEISSERIA GONORRHOEAE AS NEISSERIA CINEREA IN ASSOCIATION WITH THE VITEK® 2 NEISSERIA-HAEMOPHILUS (NH) IDENTIFICATION (ID) TEST KIT. REPEAT TESTING PROVIDED A LOW DISCRIMINATION IDENTIFICATION TO N NEISSERIA GONORRHOEA / NEISSERIA MENINGITIDIS. DUE TO SUSPICION OF NEISSERIA GONORRHOEAE BASED ON THE APPEARANCE OF THE ISOLATED COLONIES, THE CUSTOMER SENT THE ISOLATE TO A REFERENCE LABORATORY. THE REFERENCE LABORATORY OBTAINED IDENTIFICATION NEISSERIA GONORRHOEAE VIA PCR TESTING AND VITEK® 2 NH ID CARD. 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. CULTURE SUBMITTAL HAS BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. HOWEVER, THE CUSTOMER STATED THE STRAIN IS NO LONGER VIABLE FOR TESTING. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6837680 ↗
• MalfunctionAug 18, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION FOR CAMPYLOBACTER JEJUNI AS NEISSERIA CINEREA OR UNIDENTIFIED ORGANISM IN ASSOCIATION WITH VITEK® 2 NH ID TEST KIT, LOT 2450221203. 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 BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6804092 ↗
• MalfunctionAug 15, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF CAPNOCYTOPHAGA SPECIES (QUALITY CONTROL SAMPLE) IN ASSOCIATION WITH THE VITEK® 2 NEISSERIA-HAEMOPHILUS (NH) IDENTIFICATION (ID) TEST KIT. FIVE VITEK® 2 NH ID (5) TESTS WERE PERFORMED SIMULTANEOUSLY FROM THE SAME ISOLATE; ALL FIVE TESTS PROVIDED A RESULT OF LOW DISCRIMINATION BETWEEN NEISSERIA AND MORAXELLA SPECIES. 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. THE QUALITY CONTROL SAMPLE WAS NOT DIRECTLY ASSOCIATED WITH ANY PATIENT. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 6793974 ↗
• MalfunctionAug 10, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF NEISSERIA GONORRHOEAE AS NEISSERIA CINEREA IN ASSOCIATION WITH THE VITEK® 2 NEISSERIA-HAEMOPHILUS (NH) IDENTIFICATION (ID) TEST KIT. DUE TO SUSPICION OF NEISSERIA GONORRHOEAE BASED ON GRAM STAIN AND CLINICAL PRESENTATION, THE CUSTOMER PERFORMED PCR TESTING AND OBTAINED THE NEISSERIA GONORRHOEAE RESULT. THE CUSTOMER STATED THE DISCREPANT VITEK® 2 NH ID RESULT WAS NOT REPORTED TO THE TREATING PHYSICIAN; THE PCR RESULT WAS USED BY THE PHYSICIAN FOR TREATMENT DECISIONS. THERE WAS NO ADVERSE IMPACT ON THE PATIENT'S STATE OF HEALTH DUE TO THE DISCREPANT RESULT. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. HOWEVER, THE CUSTOMER STATED THE STRAIN IS NO LONGER VIABLE FOR TESTING. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6784344 ↗
• MalfunctionJul 27, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION OF A NEISSERIA SPECIES IN ASSOCIATION WITH VITEK® 2 NH CARD. CUSTOMER STATES THAT THEY TOOK ONE COLONY FROM A THAYER MARTIN DISH AND ONE FROM A CHOCOLATE AGAR DISH FOR THE SAME PATIENT, PREPARED TWO SUSPENSIONS, AND RAN TWO TESTS SIMULTANEOUSLY WITH TWO VITEK® 2 NH CARDS. THEY HAVE RECEIVED TWO DIFFERENT RESULTS: 90% PROBABILITY NEISSERIA MENINGITIDIS AND 94% PROBABILITY NEISSERIA CINEREA. THE PHYSICIAN SUSPECTED THAT THE COLONY WAS NEISSERIA GONORRHOEAE. THEREFORE, THEY ALSO PERFORMED ADDITIONAL PCR TEST AND OBTAINED A RESULT OF NEISSERIA GONORRHOEAE. CUSTOMER STATES THEY NO LONGER HAVE THE ISOLATE TO RETEST. 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 6748686 ↗
• MalfunctionJul 26, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION OF A SUSPECTED CAMPYLOBACTER BACTERIUM AS NEISSERIA CINEREA IN ASSOCIATION WITH VITEK® 2 NH CARD. THE CUSTOMER PERFORMED AN IDENTIFICATION TEST ON GRAM NEGATIVE SPIRAL BACTERIA WITH THE VITEK® 2 NH CARD. THE BACTERIUM, WHICH WAS IDENTIFIED AS NEISSERIA CINEREA, HAD BEEN FOUND FROM HUMAN FECES AND HAD GROWN ON A SELECTIVE MEDIA FOR CAMPYLOBACTER. THIS CUSTOMER EXPERIENCED 2 STRAINS WITH SAME RESULTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6744655 ↗
• MalfunctionJul 17, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 NH TEST KIT. THE CUSTOMER REPORTED THAT THE NH CARD IDENTIFIED THE BACTERIUM CAMPYLOBACTER COLI, BUT USING ANOTHER TESTING METHOD API CAMPY RESULTED IN CAMPYLOBACTER JEJUNI. THE CUSTOMER REPORTED THAT C. JEJUNI IS LIKELY THE CORRECT RESULTS BECAUSE HIPPURATE HYDROLASE TEST RESULT WAS POSITIVE. 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 6718040 ↗