Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
- Recall Initiated
- August 9, 2022
- Posted
- December 7, 2022
- Recall Number
- Z-0323-2023
- Quantity
- 1,348,000 (US)
Reason for Recall
Products were distributed in the United States without FDA authorization or clearance.
Distribution
US Distribution in states to: CA, FL, KY, and MI.
Lot / Code Info
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
Root Cause
No Marketing Application
Action Taken
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.