FDAJanuary 9, 2022device
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
acon biotech hangzhouaconacon biotech
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCWiifo Children's Tower Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by Wiifo2026-04-23
- FDASemaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development...2026-02-13
- FDASemaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing...2026-02-13
- CPSCViofairy Hair Growth Serum Bottles Recalled Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging; Sold on Amazon by FDA2026-01-29
- FDABD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F2025-11-29
- CPSCSéfralls Minoxidil Hair Generation Serum Recalled Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child Resistant Packaging; Manufactured by Guangzhou Ariel Biotech2025-08-07
- FDABartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.2025-07-22
- FDAAcoSound. Model Number: LW12-BTE-M2025-04-25
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