Reported Dec 23, 2020 · Terminated
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from…
Enterix, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Enterix, Inc. · 236 Fernwood Ave · Edison, NJ · 08837-3839
Is this the product you have?
- InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
- Lot codes and dates
- Lot Numbers770G11 and 770G21
- Amount recalled
- US: 5,256 vials (131,400 test strips); OUS:1051 vials
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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