medical Class II Updated 2020-12-23

Enterix, Inc. recalls InSure ONE Test Strips (25 pack) vials-fecal immunochemical

Recalled Product

InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 770G11 and 770G21
View official government recall

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