BioFire Diagnostics is recalling 110 kits of its BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and BIOFIRE Respiratory Panel 2.1 (RP2.1) due to a manufacturing issue. This defect may cause the tests to provide false negative results, meaning they could fail to detect a virus or bacteria that is actually present. The recall includes 53 Gastrointestinal Panel kits and 57 Respiratory Panel kits distributed across 16 states. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding these diagnostic tools.
A false negative result can lead to inappropriate antibiotic treatment, no treatment at all, or a delay in proper medical care. It may also provide false assurance to an infected individual, potentially delaying the identification of a disease outbreak and leading to further transmission of the infection to others.
Manufacturer notification via letter
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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