FDAJuly 22, 2025device
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
What to do
FDA enforcement status: Ongoing
Brands named
trinity biotechtrinity
UPCs
05391516744065
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
- 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
- FDABrand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No2024-12-13
- FDABrand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected. Component: No2024-12-13
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