VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identifi
Check against the official notice below — it lists the full affected range.
BioMérieux is recalling VITEK 2 and VITEK 2 Compact laboratory testing systems (versions 8.01, 8.02, 9.01, and 9.02) that are configured to use HL7 external communication. The recall affects approximately 8,786 systems distributed worldwide, with affected countries including Austria, Brazil, Greece, Hungary, India, Ireland, Mexico, and others, but no U.S. consignees. The issue involves a software defect where test results in the VITEK 2 system do not match the results sent to the Laboratory Information System (LIS), and when isolates are sent to the LIS more than once, the system fails to send expert-interpreted results and therapeutic corrections.
The potential safety risk identified is a false susceptible erroneous test result, which could occur when laboratory technicians manually change results in the LIS to match those in the VITEK 2 device. The recall notice does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
Reason for recall: 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). Distribution: Worldwide distribution - No US consignees affected and the countries of Andorra, Austria, Bangladesh, Bermuda, Brazil, Brunei Darussalam, El Salvador, French Guiana, French Polynesia, Gibraltar, Greece, Guadeloupe, Guam, Holy See (Vatican City State), Hong Kong, Hungary, India, Indonesia, Ireland, Lao People's Democratic Republic, Luxembourg, Macao, Malaysia, Martinique, Mexico, Myanmar, New Caled Quantity: 8786 systems Lot/code info: VITEK 2 and VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7. (System: VITEK 2 60, Reference Number: 27225, Catalog Number: C20, UDI: 03573026162351); (System: VITEK 2 60, Reference Number: 27225R, Catalog Number: C20, UDI: 03573026206765); (System: VITEK 2 XL, Reference Number: 27227, Catalog Number: C20, UDI: 03573026162375); (System: VITEK 2 XL, Reference Number: 27227R, Catalog Number: C20, UDI: 03573026206789). Each instrument has unique serial number.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.