BioFire Diagnostics is recalling 61,069 units of its BIOFIRE FILMARRAY Gastrointestinal (GI) Panel software due to an increased risk of providing false positive results for Cryptosporidium. This diagnostic tool is used to identify pathogens in patients with gastrointestinal symptoms, and an incorrect result could lead to unnecessary or inappropriate medical treatment. The recall affects Part Numbers RFIT-ASY-0104 and RFIT-ASY-0116 when used with specific older software versions. Consumers should contact their healthcare provider or the manufacturer to ensure their diagnostic systems have been updated.
A software defect can cause the diagnostic test to incorrectly identify the presence of Cryptosporidium when it is not actually there. This may result in patients receiving medical treatments they do not need or clinicians failing to look for the true cause of the patient's illness.
Software update and manufacturer notification
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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