BioFire Diagnostics, LLC is recalling 23 kits (690 pouches) of the BioFire Respiratory Panel 2.1, an in vitro diagnostic test. The recall was issued because chemicals inside the test pouch can move unexpectedly, which may cause the panel to produce false negative results or suffer from control failures. This recall affects the 30-test kit with catalog number REF: 423742 and Lot # 2649724. You should contact the manufacturer or your distributor to arrange for the return or replacement of any affected kits in your inventory.
The unintended movement of chemistry within the test pouch can cause the test to provide a negative result even when a pathogen is present. This risk of false negatives could lead to delayed or incorrect medical treatment for respiratory infections and potentially contribute to the further spread of illness.
Recall involves 23 kits total, equaling 690 individual pouches.
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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