# FDA recall Z-0323-2023

> **DEWEI MEDICAL EQUIPMENT CO LTD** · Class I · device recall initiated 2022-08-09.

## 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

- **Recall number:** Z-0323-2023
- **Recalling firm:** DEWEI MEDICAL EQUIPMENT CO LTD
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-09
- **Report date:** 2022-12-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Foshan, N/A, China

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0323-2023. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-0323-2023. Source: US FDA. Licensed CC0.

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