Recall Z-1050-2022 ยท QKP Coronavirus Antigen Detection Test System.
USA Medical, LLC
Diagnostic Kit SARS-cCo V Antigen Rapid Test
| Date | Apr 4, 2022 |
| Status | Open, Classified |
| Reason | COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed. |
| Root cause | No Marketing Application |
| Action | On 04/04/2022, US Medical LLC sent an "URGENT MEDICAL DEVICE RECALL" Letter via certified US Postal informing customers that USA Medical LLC is voluntarily recalling all COVID-19 Rapid test, labeled as Diagnostic Kit COVID-19 Antigen Rapid Test and may have included components labeled DiaTrust COVID-19 Ag Rapid Test. These COVID-19 antigen tests distributed by USA Medical have not received FDA Emergency Use Authorization, nor have these tests been cleared or approved by FDA for commercial distribution. Customers are instructed to: 1. Discontinue use, discard, or return the product back to |
| Quantity | 2055 kits |
| Distribution | U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.