Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
FDA Recall Z-0323-2023 · Posted 2022-12-07
Recalling FirmDEWEI MEDICAL EQUIPMENT CO LTD
Recall StatusOpen, Classified
Product CodeQBD
Date Initiated2022-08-09
Product Quantity1,348,000 (US)
Reason for Recall
Products were distributed in the United States without FDA authorization or clearance.
Firm 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].
Root Cause
No Marketing Application
Distribution Pattern
US Distribution in states to: CA, FL, KY, and MI.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.