FDA Medical Device Recalls (openFDA)
DEWEI MEDICAL EQUIPMENT CO LTD: Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
- Recall number
- Z-0323-2023
- Recalling firm
- DEWEI MEDICAL EQUIPMENT CO LTD
- Product
- Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
- Status
- Open, Classified
- Initiated
- 2022-08-09
- Posted
- 2022-12-07
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QBD
- Firm FEI
- 3016853433
- Firm city
- Foshan
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28