Enterix Recalls InSure ONE Test Strips Due to Potential False Positives
Enterix, Inc. is recalling InSure ONE Test Strips because they may produce false positive results, potentially leading to unnecessary medical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may lead to unnecessary invasive diagnostic procedures (colonoscopy or sigmoidoscopy), representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Enterix, Inc. is recalling InSure ONE Test Strips (25 pack) vials, Model 12045.01. These fecal immunochemical test (FIT) strips are used to qualitatively detect human hemoglobin from blood in fecal samples. The recall affects Lot Numbers 770G11 and 770G21. The product was distributed nationwide in the United States and in Australia.
The recall was initiated because the product does not meet internal testing criteria. Use of the affected test strips may result in a potential false positive test result. A false positive result may lead patients to undergo unnecessary follow-up diagnostic procedures, such as a colonoscopy or sigmoidoscopy.
Consumers who have purchased these specific lot numbers should stop using the product and contact Enterix, Inc. for further instructions or a refund.
The recalled product
- Product
- InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
- Manufacturer
- Enterix, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 770G11 and 770G21
Distribution
Distributed nationwide across the United States.
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