Recall Z-0892-2022 ยท QKP Coronavirus Antigen Detection Test System.
WHPM Inc.
First SIGN SARS-CoV-2 Antigen Test
| Date | Mar 4, 2022 |
| Status | Terminated |
| Reason | Frm became aware that a customer complaint was reported to US FDA that SARS-CoV-2 Antigen Tests were sold domestically by a pharmacy in California. These Antigen Tests have not received FDA Emergency Use Authorization, nor have these tests been cleared or approved by FDA for commercial distribution in the U.S. |
| Root cause | No Marketing Application |
| Action | On 03/04/2022, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx to customers informing them that, their SARS-CoV-2 Antigen Tests does not have FDA approvals, clearances, or emergency use authorization and cannot be distributed in the U.S. Use of the affected product could result in false-negative and/or false-positive results and could lead to a delay in the correct diagnosis and the initiation of an appropriate treatment. Customer are instructed to: -Stop/Cease using/distributing the Antigen device in their possession; -Count the tests in their possession and write the numb |
| Quantity | 535,755 tests |
| Distribution | U.S.: CA, FL, LA, MA and TX O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.