# FDA recall Z-0945-2022

> **Acon Biotech (Hangzhou) Co., Ltd.** · Class II · device recall initiated 2022-01-09.

## Product

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked

## Reason for recall

Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test results, including false negative or false positive test results.

## Distribution

US: MD, PA  International Distribution to countries of: Hungary and China.

## Key facts

- **Recall number:** Z-0945-2022
- **Recalling firm:** Acon Biotech (Hangzhou) Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-09
- **Report date:** 2022-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hangzhou, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0945-2022

## Citation

> AI Analytics. FDA recall Z-0945-2022. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0945-2022. Source: US FDA. Licensed CC0.

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