DEWEI MEDICAL EQUIPMENT CO LTD Recall 91137
Description: Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
DEWEI MEDICAL EQUIPMENT CO LTD Recall 91137 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0323-2023 |
| Event ID | 91137 |
| Event Description | Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B |
| Product Type | Devices |
| Distribution | US Distribution in states to: CA, FL, KY, and MI. |
| Quantity | 1,348,000 (US) |
| Recall Reason | Products were distributed in the United States without FDA authorization or clearance. |
| Device Classification | 20221214 |
| Device 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 |
| Center Classification Date | 20221207 |
| Recall Initiation Date | 20220809 |
| Recalling Firm | DEWEI MEDICAL EQUIPMENT CO LTD |
| Initial Notification | Other |
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