Jiangsu Well Biotech Co.,Ltd. recalls Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
- Recall date
- August 9, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0001-2023
- FDA classification
- Class I
- Brand / firm
- Jiangsu Well Biotech Co.,Ltd.
- Sold / distributed
- U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A
Why it was 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.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
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