Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Jiangsu Well Biotech Co. Recalled by Jiangsu Well Biotech Co.,Ltd. Due to Distribution of COVID-19 Ag Rapid Test kits in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Jiangsu Well Biotech Co.,Ltd. directly.
Affected Products
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Quantity: 620,000 tests
Why Was This Recalled?
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
Where Was This Sold?
This product was distributed to 1 state: CA
About Jiangsu Well Biotech Co.,Ltd.
Jiangsu Well Biotech Co.,Ltd. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report