FDAFDA · Food and drugs·Recall number Z-0590-2021
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
Published December 23, 2020 · Recall initiated: October 8, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Enterix, Inc.
- Distributor
- Worldwide distribution - US Nationwide and the country of Australia.
- Lot
- Lot Numbers: 770G11 and 770G21
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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