FDA · Medical device recall

Dewei DNA/RNA Preservation Kit…

Dec. 14, 2022 Class I

Date: Dec. 14, 2022
Risk class: Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
Status: Ongoing
Filed by: Dewei Medical Equipment Co Ltd
Product: Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Reason: Products were distributed in the United States without FDA authorization or clearance.
Distribution pattern: US Distribution in states to: CA, FL, KY, and MI.
Quantity: 1,348,000 (US)
Codes and lots: LOT / EXP DW200628 27-Jun-21 DW200520 19-May-21 DW200520 19-May-21 DW201202 01-Dec-21 DW201202 1-Dec-21 DW210103 2-Dec-22 DW210926 25-Sep-22
Recall started: Aug. 9, 2022
Device type: Microbial Nucleic Acid Storage And Stabilization Device
Root cause (FDA): No Marketing Application
What the company told customers: Starting on August 9, 2022, the firm contacted its customers through instant messaging to inform them that the affected products were not authorized, cleared, or approved by the FDA. Distributors were asked to cease selling and distributing the affected kits in U.S. immediately. On August 19, 2022, the firm followed up with its customers with an email stating the same. The firm has ceased exporting the DNA/RNA Preservation kits to the U.S. If you have any questions, email: sherry@deweilab.com.
Recall number: Z-0323-2023

Source: FDA · Medical device enforcement report, recall number Z-0323-2023. The agency record governs; check it and the company before acting.

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