BioFire Diagnostics is recalling approximately 67,613 BIOFIRE FILMARRAY Gastrointestinal (GI) Panels due to an increased risk of false positive results for Vibrio and Vibrio cholerae. This issue occurs when the test is used with specific lots of Remel Cary-Blair transport medium, potentially leading to incorrect diagnoses of bacterial infections. The affected products include both 30-test and 6-test kits distributed nationwide and internationally between May and August 2024. Consumers and healthcare providers should contact the manufacturer for further instructions regarding the use of these diagnostic kits.
A false positive result could lead to a patient receiving unnecessary treatment for a gastrointestinal infection they do not have, or failing to receive treatment for the actual underlying cause of their symptoms. While no specific injuries were reported in the recall data, incorrect diagnostic results in a clinical setting can delay proper medical care.
Manufacturer notification and guidance
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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