InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
Reported: December 23, 2020 Initiated: October 8, 2020 #Z-0590-2021
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
Details
- Recalling Firm
- Enterix, Inc.
- Units Affected
- US: 5,256 vials (131,400 test strips); OUS:1051 vials
- Distribution
- Worldwide distribution - US Nationwide and the country of Australia.
- Location
- Edison, NJ
Frequently Asked Questions
What product was recalled? ▼
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.. Recalled by Enterix, Inc.. Units affected: US: 5,256 vials (131,400 test strips); OUS:1051 vials.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 23, 2020. Severity: Moderate. Recall number: Z-0590-2021.
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