Recall Z-0564-2022 ยท QKP Coronavirus Antigen Detection Test System.
E25Bio, Inc.
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
| Date | Feb 9, 2022 (initiated Jan 27, 2022) |
| Status | Terminated |
| Reason | The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place. |
| Root cause | No Marketing Application |
| Action | On January 27, 2022, the firm began sending customers Urgent Medical Device Recall letters. Customers were instructed to do the following: Immediately examine your inventory for the affected product and quarantine any that are identified Do not use the COVID-19 Direct Antigen Rapid Test to diagnose or screen any individuals for COVID-19 Destroy the tests by placing them in the trash; alternatively, contact info@e25bio.com for assistance in removing these products from your inventory Complete and return the response form to the firm as soon as possible, indicating the number of destroyed |
| Quantity | 73,300 units |
| Distribution | US Nationwide distribution in the states of MA, FL, and HI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.