Recall Z-2382-2021 ยท QKO Reagent, Coronavirus Serological
Thera Test Laboratories, Inc.
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
| Date | Oct 5, 2020 |
| Status | Terminated |
| Reason | The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128 |
| Root cause | No Marketing Application |
| Action | The firm initiated the recall using undated letters attached to emails sent on 10/7/2020 requesting return of product. |
| Quantity | 19 kits |
| Distribution | US Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.