December 8, 2022

FDA: Class I recall of Dewei Medical Equipment’s DNA/RNA Preservation Kits

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA) on December 8 identified the recall by Dewei Medical Equipment Co of its DNA/RNA Preservation Kits as Class I, the most serious.

The kits are used to collect, preserve, and transport clinical samples that will be tested for viruses, including COVID-19.

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

Distribution dates were May 2020 to January 2022.


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