Biomerieux recalls VITEK 2 systems with HL7 configured version 8.0x and 9.0x due to potential false susceptible test results causing lab errors. Affected units may need manual result corrections.
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 VITEK 2 bacterial testing systems with specific software versions (8.01-8.02 and 9.01-9.02) that use HL7 communication. This could cause false test results where lab technicians must manually correct data in the laboratory information system, risking incorrect treatment decisions.
When HL7 communication is enabled, the VITEK 2 system may send incorrect test results to the laboratory information system (LIS). This causes lab technicians to manually correct results, which could lead to treatment errors if the system fails to send therapeutic corrections for repeated isolates.
Laboratories using VITEK 2 systems with HL7 configured software versions 8.0x or 9.0x are most at risk. Healthcare professionals handling bacterial testing with these systems may need to manually verify results.
Check if your VITEK 2 system has software version 8.01, 8.02 (8.0x), 9.01, or 9.02 with HL7 configured communication. The system may have a unique serial number or reference number listed in the product description.
Verify your VITEK 2 system's software version is 8.01, 8.02 (8.0x), 9.01, or 9.02 with HL7 configured communication.
No, this recall only applies to systems with HL7 configured communication.
The laboratory technician must manually correct results in the LIS to match the VITEK 2 system.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-1307-2021 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-1307-2021 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.
