Recall Z-0590-2021— Enterix, Inc.
Class II · Terminated
Class II FDA medical device recall by Enterix, Inc., initiated 2020-10-08, terminated 2023-01-10. It names one FDA 510(k) clearance: K170548. Product: InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.. Reason: 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.
- Recalling firm
- Enterix, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-08
- Terminated
- 2023-01-10
- Firm location
- Edison, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.