VITEK® 2 60 BLUE MOD COLORM 27225Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026162351), received between Mar 15, 2022 and Mar 15, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test Results” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2022Low Test Results; Low Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE SUSCEPTIBLE CIPROFLOXACIN RESULT IN ASSOCIATION WITH THE VITEK® 2 60 BLUE MOD COLORM 110V - (REF. 27225, SERIAL# (B)(4)) WHEN TESTING A PATIENT ESCHERICHIA COLI URINE ISOLATE. THE CUSTOMER TESTED THE E. COLI ISOLATE ON TWO (2) SEPARATE VITEK® 2 INSTRUMENTS WHILE PERFORMING A COMPARISON STUDY. ONE INSTRUMENT OBTAINED A SUSCEPTIBLE CIPROFLOXACIN RESULT WHILE THE OTHER OBTAINED A RESISTANT CIPROFLOXACIN RESULT. THE CUSTOMER TESTED THE ISOLATE USING THE CIPROFLOXACIN DISC DIFFUSION TEST METHOD, A RESISTANT RESULT WAS OBTAINED. A BIOMERIEUX FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND NOTED THE FOLLOWING ISSUES ON THE IMPACTED VITEK® 2 INSTRUMENT: LOOSE INSTRUMENT READER HEAD BELT, WORN PULLEY, AND WHITE DUST (FROM THE TEST KITS) IN THE INSTRUMENT. THE FSE THEN REPLACED THE TX 14 ASSEMBLY, INSTRUMENT BELT AND LEDGE. THE ISOLATE WAS THEN TESTED AND OBTAINED THE EXPECTED SUSCEPTIBLE CIPROFLOXACIN. THERE IS NO ADVERSE PATIENT IMPACT, THE FALSE SUSCEPTIBLE RESULT OCCURRED DURING A COMPARISON STUDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13776114 ↗