Device product
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
Z-0590-2021
Product summary
- Firm
- Enterix, Inc.
- Event
- Event 86674
- Status
- Terminated
- Classification
- Class II
- Quantity
- US: 5,256 vials (131,400 test strips); OUS:1051 vials
- Official record key
device-enforcement:Z-0590-2021
Official wording
Reason: 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
Code information: Lot Numbers: 770G11 and 770G21
Distribution pattern: Worldwide distribution - US Nationwide and the country of Australia.
Derived failure modes
-
Unknown
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