Recall Z-0323-2023 ยท QBD Microbial Nucleic Acid Storage And Stabilization Device
DEWEI MEDICAL EQUIPMENT CO LTD
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
| Date | Dec 7, 2022 (initiated Aug 9, 2022) |
| Status | Open, Classified |
| Reason | Products were distributed in the United States without FDA authorization or clearance. |
| Root cause | No Marketing Application |
| 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: sherry@deweilab.com. |
| Quantity | 1,348,000 (US) |
| Distribution | US Distribution in states to: CA, FL, KY, and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.