bioMerieux, Inc. has recalled 74 VITEK 2 automated systems running software version 8.02 due to a critical software defect. This issue prevents corrected test interpretations for antibiotic and synergy tests from being sent properly to the laboratory information system (LIS). No incidents or injuries have been reported, but the defect was identified in systems across nine U.S. states and several foreign countries. Laboratory directors should ensure their systems are updated or corrected by the manufacturer.
The software defect causes the system to omit user-corrected or expert-corrected interpretations when sending data to the lab's main computer system. This can result in incorrect antibiotic test results being reported, potentially leading to inappropriate treatment decisions for animals.
Recall affects 74 systems specifically using software version 8.02. Recall number V-0141-2022.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response