Medical device recalls High risk

DEWEI MEDICAL EQUIPMENT CO LTD recalls Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B

Recall date
August 9, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0323-2023
FDA classification
Class I
Brand / firm
DEWEI MEDICAL EQUIPMENT CO LTD
Sold / distributed
US Distribution in states to: CA, FL, KY, and MI.

Why it was recalled

Products were distributed in the United States without FDA authorization 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

Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B

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