FDA Recall
Open, Classified
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Recall: Z-0323-2023
·
Initiated August 9, 2022
Recall
- Recall Number
- Z-0323-2023
- Event Number
- 91137
- FEI Number
- 3016853433
- Product Code
- QBD
- Status
- Open, Classified
- Root Cause
- No Marketing Application
- Initiated
- August 9, 2022
- Posted
- December 7, 2022
- Address
- DEWEI MEDICAL EQUIPMENT CO LTD 5 Th Floor No.4 Building, Shiyou Industrial Park, Jun'An, Shunde Foshan China
Description
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Reason
Products were distributed in the United States without FDA authorization or clearance.
Action
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: [email protected].
Distribution
US Distribution in states to: CA, FL, KY, and MI.
Quantity
1,348,000 (US)