Recall Z-0323-2023— DEWEI MEDICAL EQUIPMENT CO LTD
Class I · Ongoing
Class I FDA medical device recall by DEWEI MEDICAL EQUIPMENT CO LTD, initiated 2022-08-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B. Reason: Products were distributed in the United States without FDA authorization or clearance..
- Recalling firm
- DEWEI MEDICAL EQUIPMENT CO LTD
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-08-09
- Firm location
- Foshan, N/A, China
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.