FDAMarch 2, 2021device
Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - FaStep Rapid Diagnostic Test *** COVID-19 IgG/IgM...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.
What to do
FDA enforcement status: Terminated
Brands named
azure biotechazure
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- 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
- 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
- FDABrand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001 2.Product composition: This device co...2025-01-24
- FDABrand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Product Description: 1. Product Overview Product Name: SARS-CoV-2 Nucleic Acid Testing Card Trade Name: Pluslife SARS-CoV-2 Card 2.Product composition:The ...2025-01-24
- FDACook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.2024-11-22
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