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, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the
Check against the official notice below — it lists the full affected range.
Biomerieux has recalled approximately 6,777 VITEK 2 Compact systems worldwide due to a potential safety risk involving false susceptible test results. The problem occurs when the system's HL7 connection is used for external communication. When this happens, test results shown in the VITEK 2 device do not match the results sent to the Laboratory Information System (LIS), requiring laboratory technicians to manually change results in the LIS to match those in the device. Additionally, when an isolate is sent more than once to the LIS, a software defect prevents the system from sending expert-reviewed interpretation results and therapeutic corrections to the LIS.
The affected systems are VITEK 2 Compact models with software versions 8.01, 8.02, 9.01, or 9.02 that have been configured with HL7 external communication. The recall affects devices distributed worldwide but indicates no US consignees were affected. The recall record does not specify a remedy or recommended action for 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: 6777 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. Each instrument has unique serial number. (System: VITEK 2 Compact 60, Reference Number: 27560, Catalog Number: C57, UDI: 03573026136796); (System: VITEK 2 Compact 30, Reference Number: 27560R, Catalog Number: C57, UDI: 03573026147501); (System: VITEK 2 Compact 30, Reference Number: 27530, Catalog Number: C57, UDI: 03573026136789); (System: VITEK 2 Compact 30, Reference Number: 27530R, Catalog Number: C57, UDI: 03573026147495); (System: VITEK 2 Compact 15, Reference Number: 27415, Catalog Number: C57, UDI: 03573026220624); (System: VITEK 2 Compact 15, Reference Number: 27415R, Catalog Number: C57, UDI: 03573026220631)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.