Recall Z-2381-2021 ยท QKO Reagent, Coronavirus Serological
Thera Test Laboratories, Inc.
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
| Date | Jul 30, 2020 |
| Status | Terminated |
| Reason | Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129 |
| Root cause | No Marketing Application |
| Action | An undated letter was issued to their customers attached to an email dated 7/30/2020 explaining the reason for recall and requesting the customer stop testing with the kit. |
| Quantity | 11 kits |
| Distribution | US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.