Class IIOngoingZ-0736-2026
GET TESTED INTERNATIONAL AB recalls Fecal Occult Blood Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Reagent, Occult Blood recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–2 of 2 recalls
Class IIOngoingZ-0725-2026
Enterix, Inc. recalls InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient…
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Enterix, Inc.NJDec 10, 2025