FDA Device recall Z-0323-2023
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
- FDA Device
- Class I
- ongoing
- Published 2022-12-14
On 2022-12-14 the FDA classified a Class I recall of Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B by Dewei Medical Equipment, citing products were distributed in the United States without FDA authorization or clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0323-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-08-09 |
| Published | 2022-12-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Dewei Medical Equipment |
| Distribution | CA, FL, KY, MI |
Product
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Reason
Products were distributed in the United States without FDA authorization or clearance.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0323-2023%22
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