BioFire Diagnostics, LLC is recalling approximately 64,594 FilmArray Gastrointestinal (GI) Panels, which are used to detect pathogens in patients. This recall includes both the 30-test kit (Part No. RFIT-ASY-0116) and the 6-test kit (Part No. RFIT-ASY-0104) due to a technical defect that may lead to false positive Norovirus results. While over 2.3 million tests are affected by this issue, no specific injuries or clinical mismanagements were reported in the data.
A false positive result for Norovirus could lead to unnecessary treatment, isolation of the patient, or a delay in diagnosing and treating the actual cause of the patient's gastrointestinal symptoms.
Professional consultation and manufacturer contact
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
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