# FDA recall Z-0001-2023

> **Jiangsu Well Biotech Co.,Ltd.** · Class I · device recall initiated 2022-08-09.

## Product

Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

## Reason for recall

Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.

## Distribution

U.S.: CA  (pending firm supplying additional distribution locations/consignee list).  O.U.S.: N/A

## Key facts

- **Recall number:** Z-0001-2023
- **Recalling firm:** Jiangsu Well Biotech Co.,Ltd.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-09
- **Report date:** 2022-10-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2023

## Citation

> AI Analytics. FDA recall Z-0001-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0001-2023. Source: US FDA. Licensed CC0.

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