enterix, inc.
1 recall on record
E
Enterix, Inc. — InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 900
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
FDAHealth