Recall Z-0590-2021 ยท KHE Reagent, Occult Blood
Enterix, Inc.
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
| Date | Oct 8, 2020 |
| Status | Terminated |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Clinical Genomocs issued Recall Notice to customers starting 08OCT2020 via email. Letter states reason for recall, health risk and action to take: Immediately examine your inventory and quarantine product subject to this recall. In addition, if you have further distributed this product, please promptly identify and notify your customers of this product recall. You may use a copy of this recall notification to support the communication to your customers. This recall should be carried out to the user (laboratory) level. Your assistance is appreciated and necessary in order to prevent patients w |
| Quantity | US: 5,256 vials (131,400 test strips); OUS:1051 vials |
| Distribution | Worldwide distribution - US Nationwide and the country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170548 | InSure ONE Enterix, Inc., Oct 5, 2017 |