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
    • 202107192
    • 202108231
    • 202109231
    • 202111082
    • 202110111
    • 202201102
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.