Hologic, Inc. is recalling 3 units of the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (REF: PRD-07400) because the kit may produce incorrect positive results for COVID-19. This recall involves Kit lot 892307 and Cartridge lot 890494. No incidents or injuries have been reported in connection with this issue.
A false positive result could lead to unnecessary medical treatments, isolation, or a delay in diagnosing the actual cause of a patient's symptoms. This error can lead to improper patient management and unnecessary psychological or social impact based on an incorrect COVID-19 diagnosis.
Includes Kit lot 892307 and Cartridge Lot 890494.
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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