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Beckman Coulter Inc. Recalls

212 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Beckman Coulter Inc..

212Total Recalls
6Critical
8.8MUnits Affected
Mar 16, 2026Most Recent
All Recalls

Every Beckman Coulter Inc. Recall

Sorted by most recent. Click any recall for full details.

212 recalls
High RiskFDA
Beckman Coulter Inc.
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that meas...
Diagnostic Devices·490 affected·Mar 20, 2013
High RiskFDA
Beckman Coulter Inc.
Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the...
Diagnostic Devices·579 affected·Feb 12, 2013
High RiskFDA
Beckman Coulter Inc.
Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative...
Diagnostic Devices·3,500 affected·Feb 12, 2013
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, an...
Diabetes Devices·28 affected·Nov 28, 2012
High RiskFDA
Beckman Coulter Inc.
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (...
Diagnostic Devices·14,409 affected·Nov 5, 2012
High RiskFDA
Beckman Coulter Inc.
UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, comput...
Medical Devices·7 affected·Sep 3, 2012
High RiskFDA
Beckman Coulter Inc.
Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay us...
Diagnostic Devices·5,266 affected·Jul 24, 2012
High RiskFDA
Beckman Coulter Inc.
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of to...
Medical Devices·137,445 affected·May 22, 2012
High RiskFDA
Beckman Coulter Inc.
TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+...
Medical Devices·146 affected·May 22, 2012
High RiskFDA
Beckman Coulter Inc.
AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and pos...
Medical Devices·468 affected·Apr 11, 2012
High RiskFDA
Beckman Coulter Inc.
Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematolo...
Diagnostic Devices·1,281 affected·Apr 3, 2012
High RiskFDA
Beckman Coulter Inc.
UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated slide preparation and stai...
Diagnostic Devices·41 affected·Dec 13, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker Stainer is a fully automated slide preparation and ...
Diagnostic Devices·41 affected·Dec 13, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System ...
Diagnostic Devices·2,442 affected·Oct 13, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456;...
Diagnostic Devices·2,442 affected·Oct 13, 2011
Medium RiskFDA
Beckman Coulter Inc.
Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) level...
Diagnostic Devices·117,385 affected·Oct 11, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro d...
Diagnostic Devices·1,756 affected·Aug 1, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro d...
Diagnostic Devices·432 affected·Aug 1, 2011
High RiskFDA
Beckman Coulter Inc.
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the A...
Diagnostic Devices·6,634 affected·Jul 27, 2011
High RiskFDA
Beckman Coulter Inc.
ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. P...
Diagnostic Devices·718 affected·Sep 22, 2010