Z-0001-2023 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 19, 2022
- Initiation Date
- August 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 620,000 tests
Product Description
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Reason for Recall
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
Distribution Pattern
U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A
Code Information
Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102,