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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.
Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantit...
Diagnostic Devices·205,744 affected·Jun 8, 2016
High RiskFDA
Beckman Coulter Inc.
Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitat...
Diagnostic Devices·4 affected·May 17, 2016
High RiskFDA
Beckman Coulter Inc.
Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-L...
Diagnostic Devices·54,351 affected·Apr 13, 2016
High RiskFDA
Beckman Coulter Inc.
Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination ...
Diagnostic Devices·43,877 affected·Apr 13, 2016
High RiskFDA
Beckman Coulter Inc.
Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipas...
Diagnostic Devices·32,926 affected·Apr 13, 2016
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quan...
Diagnostic Devices·834 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positive) panels are designed for use in determining a...
Medical Devices·751 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels are designed for use in determining antimicrobia...
Medical Devices·2,706 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automat...
Medical Devices·666 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels are designed for use in determining antimicrobia...
Medical Devices·284 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining a...
Medical Devices·715 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Diagnostic Devices·11,406 affected·Oct 13, 2015
High RiskFDA
Beckman Coulter Inc.
MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quant...
Medical Devices·5,138 affected·Sep 10, 2015
High RiskFDA
Beckman Coulter Inc.
AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated, clinical chemistry analyzers that measure analytes in patie...
Diagnostic Devices·3,084 affected·Jul 30, 2015
High RiskFDA
Beckman Coulter Inc.
AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers that measure analytes in pati...
Diagnostic Devices·2,130 affected·Jul 30, 2015
High RiskFDA
Beckman Coulter Inc.
AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated, clinical chemistry analyzers that measure analytes in patie...
Diagnostic Devices·3,355 affected·Jul 30, 2015
High RiskFDA
Beckman Coulter Inc.
Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in hum...
Diagnostic Devices·3,035 affected·Jul 28, 2015
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
Diagnostic Devices·59,965 affected·Dec 15, 2014
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
Diagnostic Devices·32,159 affected·Dec 15, 2014
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
Diagnostic Devices·31,799 affected·Dec 15, 2014
High RiskFDA
Beckman Coulter Inc.
Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoas...
Diagnostic Devices·1,519 affected·Oct 6, 2014
High RiskFDA
Beckman Coulter Inc.
UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI...
Diagnostic Devices·1,519 affected·Oct 6, 2014
High RiskFDA
Beckman Coulter Inc.
Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as ...
Medical Devices·46,050 affected·Aug 25, 2014
High RiskFDA
Beckman Coulter Inc.
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative de...
Diagnostic Devices·236 affected·Aug 21, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Br...
Medical Devices·216,240 affected·Aug 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Br...
Medical Devices·216,240 affected·Aug 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Br...
Medical Devices·216,240 affected·Aug 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Br...
Medical Devices·216,240 affected·Aug 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Br...
Medical Devices·216,240 affected·Aug 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for ...
Medical Devices·681 affected·May 14, 2014
High RiskFDA
Beckman Coulter Inc.
Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes...
Diagnostic Devices·82 affected·May 14, 2014
High RiskFDA
Beckman Coulter Inc.
UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300...
Medical Devices·3,540 affected·Apr 22, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in d...
Medical Devices·664 affected·Apr 8, 2014
High RiskFDA
Beckman Coulter Inc.
UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quanti...
Diagnostic Devices·1 affected·Nov 26, 2013
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening ...
Diagnostic Devices·2,874 affected·Nov 8, 2013
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations fo...
Diagnostic Devices·164 affected·Nov 8, 2013
High RiskFDA
Beckman Coulter Inc.
Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage: Coulter LH 780 Hematology Analyzer is a is a quantitative...
Diagnostic Devices·1,961 affected·Nov 8, 2013
High RiskFDA
Beckman Coulter Inc.
Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.
Medical Devices·768 affected·Nov 8, 2013
High RiskFDA
Beckman Coulter Inc.
Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative,...
Diagnostic Devices·16,154 affected·Oct 2, 2013
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, au...
Diagnostic Devices·1,025 affected·Sep 24, 2013
High RiskFDA
Beckman Coulter Inc.
Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitat...
Diagnostic Devices·8 affected·Sep 12, 2013
High RiskFDA
Beckman Coulter Inc.
ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analyt...
Medical Devices·4,584 affected·Sep 9, 2013
High RiskFDA
Beckman Coulter Inc.
ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measure...
Medical Devices·4,584 affected·Sep 9, 2013
High RiskFDA
Beckman Coulter Inc.
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for d...
Medical Devices·68,116 affected·Jul 17, 2013
High RiskFDA
Beckman Coulter Inc.
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5...
Diagnostic Devices·76 affected·Jun 3, 2013
High RiskFDA
Beckman Coulter Inc.
SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s...
Diagnostic Devices·3,353 affected·May 28, 2013
High RiskFDA
Beckman Coulter Inc.
AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body flui...
Medical Devices·108 affected·Apr 26, 2013
High RiskFDA
Beckman Coulter Inc.
Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, wh...
Diagnostic Devices·8,774 affected·Apr 17, 2013