FDAOctober 8, 2020device
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure, i.e., colonoscopy or sigmoidoscopy
What to do
FDA enforcement status: Terminated
Brands named
enterix
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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