Recall Z-0944-2022
SML Distribution, LLC · initiated March 4, 2022
Class I – dangerous or defective products that could cause serious health problems or death
Product
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Codes / lots: All lots: UL-AG-2110-05-Q UL-AG-2111-02-Q UL-AG-2112-01-Q UL-AG-2112-02-Q UL-AG-2201-03-Q
Reason for recall
The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
FDA-determined cause: No Marketing Application
Action taken
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.
Details
- Recall number
- Z-0944-2022
- Initiated
- March 4, 2022
- Product code
- QKP – Coronavirus Antigen Detection Test System.
- Quantity
- 209,450 units
- Distribution
- US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.
- Recalling firm
- SML Distribution, LLC, tyrone, PA