VITEK® 2 XL BLUE MOD COLORM 27227Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03573026162375), received between Dec 28, 2018 and Mar 9, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (6 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 28, 2021Class IITerminated

   bioMrieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEK 2 do not match the results sent to the LIS and the Laboratory Technician would need to change results in the LIS to match those in the VITEK 2. If the isolate is sent more than once to LIS, a software defect prevents the system from sending the expertised interpretation results and the Therapeutic Corrections (TC) is not sent to Laboratory Information Systems (LIS).

   Z-1307-2021 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF MISIDENTIFICATION RESULTS IN ASSOCIATION THE VITEK® 2 XL BLUE MOD COLORM 110V INSTRUMENT (REF. 27227, SERIAL# (B)(4)) WHEN TESTING YEAST ISOLATES FROM FIVE (5) SEPARATE PATIENTS. THE CUSTOMER REPORTED THEIR VITEK® 2 INSTRUMENT IDENTIFIED FIVE (5) PATIENT ISOLATES AS CANDIDA CIFERRII. THE CUSTOMER THEN STATED THEY OBTAINED TERMINATED CARDS. REVIEW OF THE CUSTOMER¿S DATA FOUND SEVERAL ERROR MESSAGES THAT INCLUDED A READER CAM ERROR RELATED TO CARDS NOT BEING SEATED INTO THE BACK OF THE CAROUSEL AND SUBSEQUENT CAROUSEL JAM. A BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND REPLACED THE READER HEAD BELT. FOLLOWING SERVICING BY THE FSE, THE CUSTOMER RETESTED THE PATIENT ISOLATES; EXPECTED RESULTS OF C. ALBICANS AND C. GLABRATA WERE OBTAINED. THERE IS NO ADVERSE PATIENT IMPACT; THE CUSTOMER CONFIRMED THE MISIDENTIFICATION RESULTS WERE NOT RELEASED TO THE TREATING PHYSICIAN AND NO PATIENTS WERE MISTREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712342 ↗
• MalfunctionMar 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF MISIDENTIFICATION RESULTS IN ASSOCIATION THE VITEK® 2 XL BLUE MOD COLORM 110V INSTRUMENT (REF. 27227, SERIAL# (B)(4)) WHEN TESTING YEAST ISOLATES FROM FIVE (5) SEPARATE PATIENTS. THE CUSTOMER REPORTED THEIR VITEK® 2 INSTRUMENT IDENTIFIED FIVE (5) PATIENT ISOLATES AS CANDIDA CIFERRII. THE CUSTOMER THEN STATED THEY OBTAINED TERMINATED CARDS. REVIEW OF THE CUSTOMER¿S DATA FOUND SEVERAL ERROR MESSAGES THAT INCLUDED A READER CAM ERROR RELATED TO CARDS NOT BEING SEATED INTO THE BACK OF THE CAROUSEL AND SUBSEQUENT CAROUSEL JAM. A BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND REPLACED THE READER HEAD BELT. FOLLOWING SERVICING BY THE FSE, THE CUSTOMER RETESTED THE PATIENT ISOLATES; EXPECTED RESULTS OF C. ALBICANS AND C. GLABRATA WERE OBTAINED. THERE IS NO ADVERSE PATIENT IMPACT; THE CUSTOMER CONFIRMED THE MISIDENTIFICATION RESULTS WERE NOT RELEASED TO THE TREATING PHYSICIAN AND NO PATIENTS WERE MISTREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712330 ↗
• MalfunctionMar 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF MISIDENTIFICATION RESULTS IN ASSOCIATION THE VITEK® 2 XL BLUE MOD COLORM 110V INSTRUMENT (REF. 27227, SERIAL# (B)(4)) WHEN TESTING YEAST ISOLATES FROM FIVE (5) SEPARATE PATIENTS. THE CUSTOMER REPORTED THEIR VITEK® 2 INSTRUMENT IDENTIFIED FIVE (5) PATIENT ISOLATES AS CANDIDA CIFERRII. THE CUSTOMER THEN STATED THEY OBTAINED TERMINATED CARDS. REVIEW OF THE CUSTOMER¿S DATA FOUND SEVERAL ERROR MESSAGES THAT INCLUDED A READER CAM ERROR RELATED TO CARDS NOT BEING SEATED INTO THE BACK OF THE CAROUSEL AND SUBSEQUENT CAROUSEL JAM. A BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND REPLACED THE READER HEAD BELT. FOLLOWING SERVICING BY THE FSE, THE CUSTOMER RETESTED THE PATIENT ISOLATES; EXPECTED RESULTS OF C. ALBICANS AND C. GLABRATA WERE OBTAINED. THERE IS NO ADVERSE PATIENT IMPACT; THE CUSTOMER CONFIRMED THE MISIDENTIFICATION RESULTS WERE NOT RELEASED TO THE TREATING PHYSICIAN AND NO PATIENTS WERE MISTREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712146 ↗
• MalfunctionMar 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF MISIDENTIFICATION RESULTS IN ASSOCIATION THE VITEK® 2 XL BLUE MOD COLORM 110V INSTRUMENT (REF. 27227, SERIAL# (B)(4)) WHEN TESTING YEAST ISOLATES FROM FIVE (5) SEPARATE PATIENTS. THE CUSTOMER REPORTED THEIR VITEK® 2 INSTRUMENT IDENTIFIED FIVE (5) PATIENT ISOLATES AS CANDIDA CIFERRII. THE CUSTOMER THEN STATED THEY OBTAINED TERMINATED CARDS. REVIEW OF THE CUSTOMER¿S DATA FOUND SEVERAL ERROR MESSAGES THAT INCLUDED A READER CAM ERROR RELATED TO CARDS NOT BEING SEATED INTO THE BACK OF THE CAROUSEL AND SUBSEQUENT CAROUSEL JAM. A BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND REPLACED THE READER HEAD BELT. FOLLOWING SERVICING BY THE FSE, THE CUSTOMER RETESTED THE PATIENT ISOLATES; EXPECTED RESULTS OF C. ALBICANS AND C. GLABRATA WERE OBTAINED. THERE IS NO ADVERSE PATIENT IMPACT; THE CUSTOMER CONFIRMED THE MISIDENTIFICATION RESULTS WERE NOT RELEASED TO THE TREATING PHYSICIAN AND NO PATIENTS WERE MISTREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712099 ↗
• MalfunctionMar 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF MISIDENTIFICATION RESULTS IN ASSOCIATION THE VITEK® 2 XL BLUE MOD COLORM 110V INSTRUMENT (REF. 27227, SERIAL# (B)(4)) WHEN TESTING YEAST ISOLATES FROM FIVE (5) SEPARATE PATIENTS. THE CUSTOMER REPORTED THEIR VITEK® 2 INSTRUMENT IDENTIFIED FIVE (5) PATIENT ISOLATES AS CANDIDA CIFERRII. THE CUSTOMER THEN STATED THEY OBTAINED TERMINATED CARDS. REVIEW OF THE CUSTOMER¿S DATA FOUND SEVERAL ERROR MESSAGES THAT INCLUDED A READER CAM ERROR RELATED TO CARDS NOT BEING SEATED INTO THE BACK OF THE CAROUSEL AND SUBSEQUENT CAROUSEL JAM. A BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND REPLACED THE READER HEAD BELT. FOLLOWING SERVICING BY THE FSE, THE CUSTOMER RETESTED THE PATIENT ISOLATES; EXPECTED RESULTS OF C. ALBICANS AND C. GLABRATA WERE OBTAINED. THERE IS NO ADVERSE PATIENT IMPACT; THE CUSTOMER CONFIRMED THE MISIDENTIFICATION RESULTS WERE NOT RELEASED TO THE TREATING PHYSICIAN AND NO PATIENTS WERE MISTREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712029 ↗
• MalfunctionSep 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED DELAYED RESULTS FOR SIX (6) PATIENT STREPTOCOCCUS STRAINS AND ONE ENTEROCOCCUS FAECALIS ISOLATE DUE TO ANTIBIOTIC TERMINATIONS (TRM) WITH THE VITEK® 2 XL INSTRUMENT (UDI (B)(4)). (B)(4): S. AGALACTIAE TRM FOR BENZYLPENICILLIN, CEFTRIAXONE, GENTAMICIN, MOXIFLOXACIN, INDUCIBLE RESISTANCE TO CLINDAMYCIN, CINDAMYCIN, TEICOPLANIN AND VANCOMYCIN REPORTING OF RESULTS WAS DELAYED ONE DAY. (B)(4): LOW DISCRIMINATION S. AGALACTIAE / S. DYSGALACTIAE TRM FOR BENZYLPENICILLIN, CEFTRIAXONE, GENTAMICIN, MOXIFLOXACIN AND CLINDAMYCIN REPORTING OF RESULTS WAS DELAYED THREE DAYS. (B)(4): IDENTIFICATION OF S. AGALACTIAE TRM FOR BENZYLPENICILLIN, CEFTRIAXONE AND GENTAMICIN REPEAT TEST: TRM FOR CEFTRIAXONE AND GENTAMICIN. REPORTING OF RESULTS WAS DELAYED ONE DAY BECAUSE THE RESULT WAS REPORTED WITHOUT CEFTRIAXONE. (B)(4): IDENTIFICATION OF S. SALIVARIUS SPP SALIVARIUS TRM FOR CEFTRIAXONE AND GENTAMICIN REPORTING OF RESULTS WAS DELAYED SEVEN DAYS WITH NO PATIENT IMPACT. (B)(4): S. ANGINOSUS IDENTIFICATION TRM FOR ANTIBIOTICS BENZYLPENICILLIN, CEFTRIAXONE, GENTAMICIN, MOXIFLOXACIN AND CLINDAMYCIN REPORTING OF RESULTS WAS DELAYED FIVE DAYS. THE PATIENT WAS NOT AFFECTED SINCE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526392 ↗
• MalfunctionDec 28, 2018Unable to Obtain Readings; Unable to Obtain Readings

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF DELAYED RESULTS WHEN USING THE VITEK® 2 SYSTEM (REF 27227). VITEK 2 CARDS WERE REMAINING IN THE PRELIMINARY PHASE WITH NO RESULTS BEING PROVIDED. THE VITEK 2 SYSTEM WAS STUCK IN THE INITIALIZING PROCESS SO THE INSTRUMENT WAS RESTARTED REMOTELY, BUT THE CARDS THAT HAD REMAINED IN THE PRELIMINARY PHASE WERE TERMINATED. THE CARDS REQUIRED REPEAT TESTING. THERE WAS A POWER INTERRUPTION OVERNIGHT, BUT THE SYSTEM IS PLUGGED INTO A UPS AND THE HOSPITAL'S EMERGENCY POWER SUPPLY. THE CUSTOMER STATED THERE WAS A DELAY IN REPORTING RESULTS OF GREATER THAN 24 HOURS DUE TO THE INSTRUMENT ISSUE. 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 8203955 ↗