Biomerieux recalls VITEK 2 Compact (versions 8.01-9.02) with HL7 configured external communication due to potential false susceptible test results. Lab technicians may need to manually correct LIS results, risking incorrect treatment decisions.
bioM¿rieux 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).
Biomerieux is recalling certain VITEK 2 Compact systems that may send false test results to laboratory information systems when connected via HL7. This could lead to incorrect treatment decisions if lab technicians have to manually adjust results. Affected units have specific version numbers and HL7 configuration.
When HL7 connection is active, the VITEK 2 system may send incorrect test results to the laboratory information system (LIS). This requires lab technicians to manually correct the LIS results to match the VITEK 2 system, which could lead to treatment errors if the correction is not done properly.
Laboratories using VITEK 2 Compact systems with HL7 external communication configured to version 8.01-9.02 are most at risk. These systems are used for bacterial identification and antibiotic susceptibility testing in clinical labs.
Check if your VITEK 2 Compact has version numbers 8.01, 8.02 (8.0x), 9.01, or 9.02 (9.0x) with HL7 external communication configured. Each unit has a unique serial number and specific reference numbers.
Verify your VITEK 2 Compact's version number (8.01, 8.02, 9.01, or 9.02) and HL7 configuration.
Biomerieux identified a potential safety risk where false susceptible test results may occur when HL7 connection is used, requiring lab technicians to manually correct LIS results.
Check your system version and HL7 configuration. If affected, contact Biomerieux for guidance on next steps.
Incorrect test results could lead to treatment errors if lab technicians manually correct LIS results to match the VITEK 2 system.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-1308-2021 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-1308-2021 from Biomerieux. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
