Beckman Coulter Inc.
Brea, CA
This page shows every FDA and USDA recall linked to Beckman Coulter Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
547
Total Recalls
2002
First Recall
2025
Most Recent
COULTER LH 500 Series System, Part Number: 178833, Beckman Coulter, Brea, CA. (Hematology analyzer)
Dec 22, 2007
· Device
Terminated
COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyzer)
Dec 22, 2007
· Device
Terminated
COULTER LH780 Analyzer , Part Number: 723585, Beckman Coulter, Brea, CA. (Hematology analyzer)
Dec 22, 2007
· Device
Terminated
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Oct 16, 2007
· Device
Terminated
Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5)
Mar 6, 2007
· Device
Terminated
Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645, Software Kit; CXP version 2.1 New User; P...
Feb 8, 2007
· Device
Terminated
CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 CXP Analysis Software Kit V2.1, Single User; Part #722...
Feb 8, 2007
· Device
Terminated
Cytomics FC 500 MPL with MXP software, Versions 2.0 & 2.1: Part #731419 KIT; FOC MXP 2.0 UPGRADE KIT; Part #73...
Feb 8, 2007
· Device
Terminated
Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890
Feb 7, 2007
· Device
Terminated
Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part Number 175454 Upgrade S...
Jan 9, 2007
· Device
Terminated
FC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL...
Dec 27, 2006
· Device
Terminated
Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1
Nov 21, 2006
· Device
Terminated
UniCel Dxl 800 Access Immunoassay Systems Wash Buffer, Part Number 8547197 Wash Buffer
Sep 23, 2006
· Device
Terminated
FP1000 Cell Preparation System Part Number 624922
Aug 31, 2006
· Device
Terminated
UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems , Part Numbers: A20463-Software version 1.0, A...
Aug 26, 2006
· Device
Terminated
Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200
Aug 1, 2006
· Device
Terminated
Cytomics FC 500 Flow Cytometry System Part Numbers 626553 (TN; FC500 with UPS), 6605627 (TN; 5 CLR, FC500 (100...
Jul 26, 2006
· Device
Terminated
Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834
Jul 18, 2006
· Device
Terminated
SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.
May 18, 2006
· Device
Terminated
UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier
Mar 3, 2006
· Device
Terminated
COULTER LH 700 Series Hematology Analyzer, PN
6605632 and 6605632R
Feb 4, 2006
· Device
Terminated
COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 66...
Feb 4, 2006
· Device
Terminated
Cytomics FC500 with
CXP Software
Jan 11, 2006
· Device
Terminated
Synchron LX Systems Version 4.5
Operating Software
Oct 6, 2005
· Device
Terminated
Access Immunoassay Systems Assay Protocol: Dil-AFP.
Aug 23, 2005
· Device
Terminated
Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0
Aug 17, 2005
· Device
Terminated
DL 2000 Data Manager
Aug 16, 2005
· Device
Terminated
Power Processor 3060 Tube Refrigerated Stockyard, P/N 6915556.
Aug 13, 2005
· Device
Terminated
Aqueduct Hematology Workflow Manager, software
Aug 10, 2005
· Device
Terminated
Beckman Coulter 1500 Series Hematology Automation System;
Part Number:
988609 (LH Basic Uint)
988610 (LH Co...
Jul 22, 2005
· Device
Terminated
Potassium Electrode Tip;
Part No.s:
668281 Tip Assembly- Synchron Family
669117 Packaged- Synchron Family
4411...
Jun 28, 2005
· Device
Terminated
Access Immunoasay Systems Digoxin Reagent
Mar 8, 2005
· Device
Terminated
COULTER LH 750 Hematology Analyzer.
Feb 10, 2005
· Device
Terminated
UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels).
Dec 28, 2004
· Device
Terminated
ACT diff 2 Analyzer
(Automated differential cell counter)
Dec 21, 2004
· Device
Terminated
CXP software for Cytomics FC500 Cytometer
Nov 30, 2004
· Device
Terminated
DL2000 Data Manager Software, Version 6.4.108
Nov 30, 2004
· Device
Terminated
SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465
Nov 30, 2004
· Device
Terminated
Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer.
Nov 30, 2004
· Device
Terminated
CXP Software Version 1.0 and 1.1 (operating software for Cytomics FD500 Cytometer.
Part numbers: 624281, 6235...
Nov 30, 2004
· Device
Terminated
COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The...
Sep 2, 2004
· Device
Terminated
SYNCHRON Clinical Systems Enzyme Validator Kit
Aug 17, 2004
· Device
Terminated
DataLink 2000 Data Manager
Jul 28, 2004
· Device
Terminated
IMMAGE IGALC Reagent
Part Number: 447460
Jul 23, 2004
· Device
Terminated
Immage Antidioxyribonuclease B (DNB) reagent
part no. 447480
Jul 23, 2004
· Device
Terminated
IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electro...
Jul 23, 2004
· Device
Terminated
Synchron Liquid Comprehensive Chemistry Control Serum.
Part numbers: 660710, 657365.
Jul 23, 2004
· Device
Terminated
Synchron Systems Lipid Calibrator (HDLD)
Part 650218
Jul 23, 2004
· Device
Terminated
Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.
Jul 23, 2004
· Device
Terminated
IMMAGE IgM Reagent
Part No.: 447610
Jul 23, 2004
· Device
Terminated