Jiangsu Well Biotech Co.,Ltd. recalls CO-02 COVID-19 Ag Rapid Test kits sold without FDA emergency use authorization or pre-market approval. Consumers should check lot numbers for affected units.
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
Jiangsu Well Biotech's CO-02 COVID-19 Ag Rapid Test kits were recalled because they were distributed in the U.S. without FDA emergency use authorization or pre-market approval. This means the products may not be safe or effective for use.
The kits were distributed without FDA emergency use authorization or pre-market approval. This means they might not be safe or effective for use in the U.S., potentially leading to incorrect test results.
Anyone who purchased the CO-02 COVID-19 Ag Rapid Test kits from the listed lot numbers. People using these kits for testing without proper regulatory approval may be at risk of inaccurate results.
Check the product label for catalog number CO-02. Affected lots include 202107192, 202108231, 202109231, 202111082, 202110111, and 202201102.
Look for the lot numbers 202107192, 202108231, 202109231, 202111082, 202110111, or 202201102 on the test kit packaging.
The recall states these kits were distributed without FDA emergency use authorization or pre-market approval, so they may not be safe or effective for use.
Check the product label for catalog number CO-02 and lot numbers 202107192, 202108231, 202109231, 202111082, 202110111, or 202201102.
The recall does not specify a remedy, so contact the manufacturer for guidance on next steps.
We’ve drafted a message you can send Jiangsu Well Biotech to request your refund or repair — edit it as you like.
Subject: Recall Z-0001-2023 — Jiangsu Well Biotech Jiangsu Well Biotech Hello, I own a Jiangsu Well Biotech that is covered by recall Z-0001-2023 from Jiangsu Well Biotech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
