October 26, 2022

FDA: Class I recall of Jiangsu Well Biotech COVID-19 Ag Rapid Test

By: Judy Mathias
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Editor's Note

The Food and Drug Administration (FDA) on October 12 identified the recall of Jiangsu Well Biotech’s COVID-19 Ag Rapid Test Devices as Class I, the most serious.

The recall was initiated because the tests were distributed to US customers without authorization, clearance, or approval from the FDA.

No complaints, injuries, or deaths have been reported.

Distribution dates were July 23, 2021 to January 23, 2022.

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