FDA recall Z-0323-2023

DEWEI MEDICAL EQUIPMENT CO LTD · Class I · device

Product

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

US Distribution in states to: CA, FL, KY, and MI.

Key facts

Status: Ongoing
Initiation date: 2022-08-09
Report date: 2022-12-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Foshan, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0323-2023