Recall Z-0879-2023 ยท QKP Coronavirus Antigen Detection Test System.
Detect Headquarters
Detect Covid-19 Test Product/Model Number: 21205
| Date | Jan 4, 2023 (initiated Dec 8, 2022) |
| Status | Open, Classified |
| Reason | There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community. |
| Root cause | Component design/selection |
| Action | On December 8, 2022, the firm notified affected enterprise/wholesale customers through email with subject line "URGENT: Voluntary Recall of Three Lots of Detect Covid-19 Tests". Direct customers were notified on December 12, 2022. Customers were instructed to locate unused tests from the affected lots and dispose of them. Customers may receive a refund for the recalled tests once they complete an acknowledgement form and return it to Detect. |
| Quantity | 10142 (US); 960 OUS |
| Distribution | Domestic distribution nationwide. Foreign distribution to Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.