Z-0590-2021 Class II Terminated
FDA device recall Z-0590-2021 was initiated by Enterix, Inc. on October 8, 2020 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated January 10, 2023). Affected quantity: US: 5,256 vials (131,400 test strips); OUS:1051 vials.
Recall Details
- Product Type
- Devices
- Report Date
- December 23, 2020
- Initiation Date
- October 8, 2020
- Termination Date
- January 10, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 5,256 vials (131,400 test strips); OUS:1051 vials
Product Description
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
Reason for Recall
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
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Australia.
Code Information
Lot Numbers: 770G11 and 770G21