Recall archive / FDA device enforcement
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B — FDA record Z-0323-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 9, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
- Reason
- Products were distributed in the United States without FDA authorization or clearance.
- Classification
- Class I
- Recalling firm
- DEWEI MEDICAL EQUIPMENT CO LTD
- Quantity
- 1,348,000 (US)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0323-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution in states to: CA, FL, KY, and MI.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 14, 2022
- Recall initiation date
- Aug 9, 2022
- Center classification date
- Dec 7, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.