Device product
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Z-0944-2022
Product summary
- Event
- Event 89975
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 209,450 units
- Official record key
device-enforcement:Z-0944-2022
Official wording
Reason: The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
Code information: 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
Distribution pattern: US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.
Derived failure modes
-
Unknown
The product was distributed without FDA authorization or clearance for marketing and distribution in the US.