Hologic, Inc. is recalling 306 units of the Aptima HPV Assay, a laboratory test used to detect high-risk human papillomavirus (HPV). The recall was initiated because the product may generate invalid or false negative results, which could lead to incorrect patient diagnosis or delayed treatment. Affected kits were distributed to clinical laboratories and healthcare facilities in nine U.S. states and Puerto Rico.
A false negative result means the test may incorrectly indicate that a patient does not have HPV when they actually do. This can lead to a lack of necessary follow-up care or treatment for a potentially serious infection.
Master Lot 929785 contains one Refrigerated Box (PN 302883) and one Room Temperature Box (PN 302885).
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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