Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) Recalled by Acon Biotech (Hangzhou) Co., Ltd. Due to Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test...

Date: January 9, 2022
Company: Acon Biotech (Hangzhou) Co., Ltd.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Acon Biotech (Hangzhou) Co., Ltd. directly.

Affected Products

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

Quantity: 303,760

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 2 states: MD, PA

Affected (2 states)Not affected

About Acon Biotech (Hangzhou) Co., Ltd.

Acon Biotech (Hangzhou) Co., Ltd. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report