Recall Z-0944-2022 ยท QKP Coronavirus Antigen Detection Test System.
SML Distribution, LLC
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
| Date | Mar 4, 2022 |
| Status | Open, Classified |
| Reason | The product was distributed without FDA authorization or clearance for marketing and distribution in the US. |
| Root cause | No Marketing Application |
| Action | The firm initially contacted affected customers by phone between March 4 and March 12, 2022. On March 21, 2022, the firm followed up with emails to each affected distributor with subject line "IMPORTANT!!! Recall Notice" which included a recall letter attachment. Customers were asked to immediately return all unused product. The firm sent an additional email on March 25, 2022 which instructed customers to not rely on the recalled tests to make medical decisions. As of April 9, 2022, the full recall notice can be found at www.smldistribution.com. |
| Quantity | 209,450 units |
| Distribution | US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.