BioFire Diagnostics is recalling 4,440 FilmArray 2.0 and FilmArray Torch diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024. These medical diagnostic systems were calibrated with faulty internal equipment that may cause the devices to report higher-than-actual melting temperatures during testing. This defect can lead to inaccurate medical results, including false positive results for Salmonella and Giardia, as well as false positive or negative results for Norovirus and MRSA.
Incorrect test results could lead to improper patient treatment, unnecessary medical procedures, or a failure to treat a serious infection. No specific injuries have been reported, but the calibration error significantly increases the likelihood of medical errors for critical pathogens.
Professional recalibration or equipment evaluation.
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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