Acon Biotech (Hangzhou) Co., Ltd.: Medical Device Recall in 2022 - (Recall #: Z-0945-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 9, 2022

Date Posted: April 27, 2022

Recall Number: Z-0945-2022

Event ID: 89755

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.

Status: Ongoing

Product Quantity: 303,760

Code Information:

Lots: COV1080201, COV1105014

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated