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Dewei Medical Equipment Co. Recalls DNA/RNA Preservation Kits That Are Not Authorized, Cleared, or Approved by the FDA
Dewei Medical Equipment Co. is recalling DNA/RNA Preservation Kits because these products were distributed to U.S. customers without authorization, clearance, or approval from the FDA. This means there is a risk for false negative, false positive, or misinterpretation of results if these products are used to detect SARS-CoV-2.
The U.S. Food and Drug Administration has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
Questions?
Customers with questions about this recall should contact Dewei Medical Equipment Co. at service@deweilab.com
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