Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
A medical device manufacturer is recalling Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B due to Products were distributed in the United States without FDA authorization or clearance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Products were distributed in the United States without FDA authorization or clearance.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IN, KY, MI
Page updated: Jan 10, 2026