Reported Oct 19, 2022 · Ongoing
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Jiangsu Well Biotech Co.,Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Jiangsu Well Biotech Co.,Ltd. · No 9 Changyang Rd West · Changzhou, N/A · N/A
Is this the product you have?
- Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
- Lot codes and dates
- Catalog NumberCO-02
- UDI-DI CodeNo
- UDI Codes provided Lot Numbers
202107192202108231202109231202111082202110111202201102
- Amount recalled
- 620,000 tests
Where it was sold
Why it was recalled
Stop using this product now
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
Using this product could cause serious injury, illness or death — stop using it now.
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