Enterix, Inc. has recalled 201,426 InSure ONE Fecal Immunochemical Test (FIT) kits because certain test cards may fail to detect human hemoglobin in stool samples. The recall includes the POL Patient Kit 10-packs (Model 90010), 25-packs (Model 90025), and Combo Packs (Model 90030) that utilize Test Card Lot TT241102. These kits were manufactured between July 23, 2025, and September 12, 2025.
The affected test cards failed sensitivity testing, which can lead to false negative results. A false negative may cause a patient or healthcare provider to incorrectly believe there is no gastrointestinal bleeding, potentially delaying the diagnosis and treatment of serious conditions like colorectal cancer.
Affected only when used with Test Card Lot TT241102.
Affected only when used with Test Card Lot TT241102.
Affected only when used with Test Card Lot TT241102.
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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