Beckman Coulter Inc.
227 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Aug 21, 2013
ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage…
FDA Devices Moderate Aug 7, 2013
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This sy…
FDA Devices Moderate Jul 3, 2013
SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s), UniCel¿ D…
FDA Devices Moderate Jun 5, 2013
Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in c…
FDA Devices Moderate Jun 5, 2013
AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, includin…
FDA Devices Moderate May 1, 2013
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analyte…
FDA Devices Moderate Apr 10, 2013
Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitativ…
FDA Devices Moderate Apr 10, 2013
Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quant…
FDA Devices Moderate Mar 13, 2013
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
FDA Devices Moderate Jan 2, 2013
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total …
FDA Devices Moderate Jan 2, 2013
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part…
FDA Devices Moderate Dec 26, 2012
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels i…
FDA Devices Moderate Nov 28, 2012
UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic de…
FDA Devices Moderate Nov 28, 2012
UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro diagnostic de…
FDA Devices Moderate Nov 28, 2012
UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI Immunoassay System is an in…
FDA Devices Moderate Oct 31, 2012
UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, computercontrolled…
FDA Devices Moderate Oct 24, 2012
AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical…
FDA Devices Moderate Oct 17, 2012
Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer …
FDA Devices Moderate Oct 17, 2012
Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Acce…
FDA Devices Moderate Oct 17, 2012
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, to…
FDA Devices Moderate Oct 17, 2012
TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/…
FDA Devices Low Aug 29, 2012
Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human s…
FDA Devices Moderate Aug 29, 2012
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vit…
FDA Devices Moderate Aug 29, 2012
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Re…
FDA Devices Moderate Aug 29, 2012
UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device …
FDA Devices Moderate Aug 29, 2012
UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker Stainer is a fully automated slide preparation and staining dev…
FDA Devices Moderate Aug 29, 2012