Z-0944-2022 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2022
- Initiation Date
- March 4, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 209,450 units
Product Description
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Reason for Recall
The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
Distribution Pattern
US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.
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