Z-0323-2023 Class I Ongoing
FDA device recall Z-0323-2023 was initiated by DEWEI MEDICAL EQUIPMENT CO LTD on August 9, 2022 and is designated Class I. Reason for recall: Products were distributed in the United States without FDA authorization or clearance. The recall status is ongoing. Affected quantity: 1,348,000 (US).
Recall Details
- Product Type
- Devices
- Report Date
- December 14, 2022
- Initiation Date
- August 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,348,000 (US)
Product Description
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Reason for Recall
Products were distributed in the United States without FDA authorization or clearance.
Distribution Pattern
US Distribution in states to: CA, FL, KY, and MI.
Code Information
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