Abbott Molecular, Inc. is recalling approximately 28,386 Abbott Alinity m HPV and STI AMP Kits because they may produce invalid test results. The recall was initiated after an increase in error codes indicated that iron is leaching from the system's pump into the testing solution, causing the test's positive control to become non-reactive. While no injuries have been reported, this defect can lead to diagnostic delays or the need to re-test patients. These kits were distributed to hospitals and diagnostic laboratories worldwide.
Iron leaching into the test solution can interfere with the chemical reaction, causing the system to fail to recognize the positive control and resulting in an invalid test result. This failure can cause significant delays in the diagnosis and treatment of human papillomavirus (HPV) or other sexually transmitted infections (STIs).
Used with the Alinity m System; Recall #: Z-0233-2025.
Used with the Alinity m System; Recall #: Z-0234-2025.
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.
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Sources: FDA iRES · Raw API Response
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