Z-0323-2023Class I

Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B

Name: Z-0323-2023 Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Creator: Dewei Medical Equipment Co Ltd
Published: 2022-08-09
License: https://open.fda.gov/license/

Dewei Medical Equipment Co Ltd / initiated 2022-08-09 / Open, Classified

FDA source

DEWEI MEDICAL EQUIPMENT CO LTD began a recall of Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B on 2022-08-09. FDA classified it as Class I and gives the reason as "Products were distributed in the United States without FDA authorization or clearance". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0323-2023
Classification: Class I
Status: Open, Classified
Initiated: 2022-08-09
Posted: 2022-12-07
Recalling firm: Dewei Medical Equipment Co Ltd
Product: Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Product code: QBD Microbial Nucleic Acid Storage And Stabilization Device
Reason for recall: Products were distributed in the United States without FDA authorization or clearance.
FDA 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: [email protected].
Quantity in commerce: 1,348,000 (US)
Distribution: US Distribution in states to: CA, FL, KY, and MI.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0323-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0323-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-07

Product code QBD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)