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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.
Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpe...
Medical Devices·41 affected·Sep 17, 2018
CriticalFDA
Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The U...
Diagnostic Devices·5,414 affected·Jul 30, 2018
CriticalFDA
Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same ...
Diagnostic Devices·2,059 affected·Jul 30, 2018
RecallFDA
Beckman Coulter Inc.
Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive its...
Medical Devices·25 affected·May 24, 2018
RecallFDA
Beckman Coulter Inc.
Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sortin...
Medical Devices·495 affected·May 24, 2018
RecallFDA
Beckman Coulter Inc.
Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intellige...
Medical Devices·283 affected·May 24, 2018
RecallFDA
Beckman Coulter Inc.
Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc...
Medical Devices·58 affected·May 24, 2018
RecallFDA
Beckman Coulter Inc.
Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter Biomedical GmbH The iPAW 4.2 User Kit (PN B7348...
Medical Devices·14 affected·May 24, 2018
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identificatio...
Medical Devices·686 affected·May 4, 2018
High RiskFDA
Beckman Coulter Inc.
BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 80...
Diabetes Devices·2,225 affected·Mar 2, 2018
High RiskFDA
Beckman Coulter Inc.
BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-33...
Medical Devices·5,247 affected·Mar 2, 2018
High RiskFDA
Beckman Coulter Inc.
AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample proce...
Medical Devices·73 affected·Jan 18, 2018
CriticalFDA
Beckman Coulter Inc.
1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for i...
Diagnostic Devices·3,115 affected·Jan 12, 2018
High RiskFDA
Beckman Coulter Inc.
iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro...
Diabetes Devices·14,340 affected·Dec 4, 2017
CriticalFDA
Beckman Coulter Inc.
Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualit...
Diagnostic Devices·227 affected·Nov 6, 2017
CriticalFDA
Beckman Coulter Inc.
UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitat...
Diagnostic Devices·2 affected·Nov 6, 2017
High RiskFDA
Beckman Coulter Inc.
UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
Medical Devices·15 affected·Nov 3, 2017
High RiskFDA
Beckman Coulter Inc.
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except tha...
Medical Devices·1 affected·Nov 3, 2017
High RiskFDA
Beckman Coulter Inc.
AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL...
Diagnostic Devices·268 affected·Oct 2, 2017
High RiskFDA
Beckman Coulter Inc.
Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating ...
Diabetes Devices·0 affected·Aug 24, 2017
High RiskFDA
Beckman Coulter Inc.
AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
Diagnostic Devices·213 affected·Aug 21, 2017
High RiskFDA
Beckman Coulter Inc.
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, ...
Diagnostic Devices·320 affected·Jul 20, 2017
High RiskFDA
Beckman Coulter Inc.
Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all norma...
Medical Devices·3,326 affected·Jun 26, 2017
High RiskFDA
Beckman Coulter Inc.
Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting syst...
Diagnostic Devices·43 affected·May 22, 2017
High RiskFDA
Beckman Coulter Inc
Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea,...
Diabetes Devices·4,444 affected·May 15, 2017
High RiskFDA
Beckman Coulter Inc.
Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
Medical Devices·249,597 affected·May 9, 2017
High RiskFDA
Beckman Coulter Inc.
Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(...
Diagnostic Devices·3,158 affected·Apr 24, 2017
High RiskFDA
Beckman Coulter Inc.
Access BR Monitor, Part No. 387620
Medical Devices·45,278 affected·Apr 13, 2017
High RiskFDA
Beckman Coulter Inc.
Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) conc...
Diagnostic Devices·12,665 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human ser...
Diagnostic Devices·50,645 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high dens...
Diagnostic Devices·91,996 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human se...
Diagnostic Devices·128,718 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for...
Diagnostic Devices·188 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Medical Devices·889 affected·Mar 10, 2017
High RiskFDA
Beckman Coulter Inc.
Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Syst...
Diagnostic Devices·851 affected·Mar 7, 2017
High RiskFDA
Beckman Coulter Inc.
UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 Product Usage: The Access 2 and UniCel DxI Access Immunoassa...
Diagnostic Devices·851 affected·Mar 7, 2017
High RiskFDA
Beckman Coulter Inc.
Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diag...
Diagnostic Devices·851 affected·Mar 7, 2017
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinic...
Diagnostic Devices·2 affected·Feb 13, 2017
High RiskFDA
Beckman Coulter Inc.
iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-716...
Diabetes Devices·3,175 affected·Jan 30, 2017
RecallFDA
Beckman Coulter Inc.
AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. Auto...
Medical Devices·4 affected·Dec 21, 2016
High RiskFDA
Beckman Coulter Inc.
DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
Medical Devices·1,282 affected·Dec 19, 2016
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304
Medical Devices·4,657 affected·Dec 19, 2016
High RiskFDA
Beckman Coulter Inc.
MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility ...
Medical Devices·131 affected·Oct 25, 2016
High RiskFDA
Beckman Coulter Inc.
Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Acces...
Diagnostic Devices·357 affected·Oct 24, 2016
High RiskFDA
Beckman Coulter Inc.
AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer sys...
Diagnostic Devices·2,367 affected·Oct 19, 2016
High RiskFDA
Beckman Coulter Inc.
AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four flor...
Diagnostic Devices·148 affected·Sep 6, 2016
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellul...
Medical Devices·5,282 affected·Aug 8, 2016
CriticalFDA
Beckman Coulter Inc.
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions ...
Medical Devices·759 affected·Aug 4, 2016