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Manufacturers
Beckman Coulter Inc
Manufacturer Address
Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
Source
USFDA
117 Events
Recall of DL 2000 Data Manager
Recall of UniCel Dxl 800 Access Immunoassay System, P/N 973100.
Recall of Coulter LH750 Hematology Analyzer. Part Number 6605632.
Recall of Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).
Recall of DL 2000 Data Manager, Software Version 6.2
Recall of Synchron Systems Hemoglobin A1c (HbA1c) Reagent
Recall of IMMAGE IGALC Reagent || Part Number: 447460
Recall of IMMAGE IGMLC Reagent || Part Number: 447470
Recall of Synchron Systems Prealbumin Reagent || Part Number: 475106
Recall of IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. || Part Numbers: || 446360 (250 test kit) || 446260 (50 test kit) || 444970 (10 test kit)
Recall of DataLink 2000 Data Manager
Recall of Customized Automation Centrifuge, First and Second Generation.
Recall of IMMAGE IgM Reagent || Part No.: 447610
Recall of Array Systems Calibrator 5 || Part No. 465250
Recall of LDL Cholesterol Reagent (LDLD) || Part No. 969706
Recall of Power Processor Aliquot Tube Labels || Part 800255
Recall of Immage Antidioxyribonuclease B (DNB) reagent || part no. 447480
Recall of SYNCHRON Clinical Systems Enzyme Validator Kit
Recall of Device Recall Access Immunoassay Systems, Discrete photometric chemistry analyzer
Recall of CXP software for Cytomics FC500 Cytometer
Recall of DL2000 Data Manager Software, Version 6.4.108
Recall of ACT diff 2 Analyzer || (Automated differential cell counter)
Recall of Device Recall Beckman Coulter, COULTER LH 750
Recall of Access Immunoasay Systems Digoxin Reagent
Recall of Power Processor 3060 Tube Refrigerated Stockyard, P/N 6915556.
Recall of Potassium Electrode Tip; || Part No.s: || 668281 Tip Assembly- Synchron Family || 669117 Packaged- Synchron Family || 441104 Electrode Assembly- EL-ISE || 445604 Electrode Packaged- EL-ISE
Recall of Beckman Coulter 1500 Series Hematology Automation System; || Part Number: || 988609 (LH Basic Uint) || 988610 (LH Connection Unit)
Recall of Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0
Recall of Access Immunoassay Systems Assay Protocol: Dil-AFP.
Recall of Device Recall Cytomics FC500 with CXP Software
Recall of Device Recall COULTER LH 700 Series Hematology Analyzer
Recall of Device Recall COULTER GEN.S Series Hematology Analyzer
Recall of Device Recall Beckman Coulter UniCel Dxl 800 Access Immunoassay System
Recall of SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.
Recall of Device Recall Beckman Coulter Cytomics FC 500 Flow Cytometry System
Recall of Device Recall UniCel DxC Synchron Clinical Systems
Recall of Device Recall Beckman Coulter FP1000 Cell Preparation System
Recall of Device Recall UniCel Dxl Access Immunoassay System
Recall of Device Recall Cytomics Flow Cytometry System
Recall of Device Recall Beckman Coulter Expo 32 ADC
Recall of Device Recall Cytomics FC 500
Recall of Device Recall Cytomics FC 500 MPL
Recall of Device Recall CXP Analysis Software
Recall of Aqueduct Hematology Workflow Manager, software
Recall of Coulter AcT 5diff Autoloader (AL) Hematology Analyzer
Recall of Synchron Liquid Comprehensive Chemistry Control Serum.
Recall of Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent
Recall of Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.
Recall of CXP Software Version 1.0 and 1.1 (operating software for Cytomics FD500 Cytometer.
Recall of COULTER LH 500 Hematology Analyzer
Recall of Coulter LH500 Hematology Analyzer
Recall of Beckman Coulter Access Immunoassay System CEA
Recall of UniCel DxC 600 PRO
Recall of UniCel DxC 800 PRO
Recall of COULTER LH750 Analyzer
Recall of COULTER LH780 Analyzer
Recall of COULTER LH 500 Series System
Recall of COULTER GENS System
Recall of UniCel DxC 800
Recall of UniCel DxC 600i
Recall of Synchron LX20 Clinical Chemistry System
Recall of Synchron LX20 PRO Clinical Chemistry System
Recall of Synchron LXi 725 Clinical Chemistry System
Recall of UniCel DxC 600
Recall of MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
Recall of SYNCHRON LXi 725 System
Recall of Access and Access 2 Immunoassay System
Recall of Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System
Recall of UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron Access Clinical System
Recall of FC 500 with CXP Acquisition Software
Recall of Device Recall FP1000 Cell Preparation System
Recall of Device Recall FC 500 with UPS
Recall of Device Recall FlowCount Fluorospheres
Recall of Device Recall Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1
Recall of Device Recall Cytomics FC 500 Flow Cytometry System with CXP Software, Software Version 2.2
Recall of Device Recall FC 500 120V
Recall of Device Recall CXP analysis SW V2.1 single user
Recall of Device Recall CXP analysis SW V2.1 single user upgrade
Recall of Device Recall CXP analysis SW V2.1, 3 User Pack
Recall of Device Recall CXP analysis SW V2.1, 5 User Pack
Recall of Device Recall CXP analysis SW V2.1, 15 User Pack
Recall of Device Recall CXP analysis SW V2.1, 5 network user with Romlock
Recall of Device Recall CXP analysis SW V2.1, 10 network user with Romlock
Recall of Device Recall CXP analysis SW V2.1, 15 network user with Romlock
Recall of Device Recall SW Kit, CXP Analyis SW V2.2 Single User
Recall of Device Recall SW Kit, CXP Analyis SW V2.2 Single User Upgrade
Recall of Device Recall SW Kit, CXP Analyis SW V2.2, 3 User
Recall of Device Recall SW Kit, CXP Analyis SW V2.2, 5 User
Recall of Device Recall SW Kit, CXP Analyis SW V2.2, 15 User
Recall of Device Recall SW Kit, CXP Analyis SW V2.2, 5 User Network
Recall of Device Recall SW Kit, CXP Analyis SW V2.2, 10 User Network
Recall of Device Recall SW Kit, CXP Analyis SW V2.2, 15 User Network
Recall of Device Recall UniCel Dxl Access Immunoassay Systems Reaction Vessels
Recall of Device Recall Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager
Recall of Device Recall Vidiera NsP Nucleic Sample Preparation
Recall of Device Recall IMMAGE CReactive Protein (CRP) Reagent
Recall of Device Recall Access Immunoassay Systems Hybritech free PSA Calibrator
Recall of Device Recall Coulter LH SlideMaker
Recall of Device Recall GENS SlideMaker
Recall of Device Recall Access Immunoassay Systems Hybritech PSA Calibrator
Recall of Device Recall Synchron Acetaminophen (ACTM) Reagent
Recall of Synchron Systems Acetaminophen Reagent, part No. 472169.
Recall of Synchron LX Clinical Systems, Operating Software, All versions.
Recall of Synchron CX (and) Synchron LX Systems Microalbumin Calibrator.
Recall of Synchron Systems Lipid Calibrator (HDLD)
Recall of Synchron LX Clinical Systems Software
Recall of SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465
Recall of 862.2160 Discrete photometric chemistry analyzer
Recall of Synchron LX Systems Version 4.5
Recall of Cytomics FC500 MPL with MXP Software
Recall of Access
Recall of COULTER LH 700 Series
Recall of Access Ultrasensitive Insulin Assay Kit
Recall of Access Power Supply Assembly Sled
Recall of UniCel Dxl 800 Access lmmunoassay System
Recall of Cytomics FC 500 Flow Cytometry System with CXP Software
Recall of SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
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117 devices in the database
DL 2000 Data Manager
Model / Serial
Not Applicable but refers to software version 6.4.109f
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide.
Product Description
DL 2000 Data Manager
UniCel Dxl 800 Access Immunoassay System, P/N 973100.
Model / Serial
All software versions pior to version 1.4
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
UniCel Dxl 800 Access Immunoassay System, P/N 973100.
Coulter LH750 Hematology Analyzer. Part Number 6605632.
Model / Serial
Software versions 2A2 and 2B1.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Coulter LH750 Hematology Analyzer. Part Number 6605632.
Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Val...
Model / Serial
Lot M207140
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).
DL 2000 Data Manager, Software Version 6.2
Model / Serial
Version 6.2
Distribution
Nationwide.
Product Description
DL 2000 Data Manager, Software Version 6.2
112 more
45 manufacturers with a similar name
Learn more about the data
here
Beckman Coulter Inc
Manufacturer Parent Company (2017)
Danaher Corporation
Source
NIDFSINVIMA
Beckman Coulter INC
Manufacturer Parent Company (2017)
Danaher Corporation
Source
NIDFSINVIMA
BECKMAN COULTER INC || Importer: ROCHEM BIOCARE COLOMBIA S.A.S
Manufacturer Parent Company (2017)
Danaher Corporation
Source
NIDFSINVIMA
BECKMAN COULTER INC || Imported by: ROCHEM BIOCARE COLOMBIA || S.A y BECKMAN COULTER COLOMBIA S....
Manufacturer Parent Company (2017)
Danaher Corporation
Source
NIDFSINVIMA
BECKMAN COULTER INC || Imported by: ROCHEM BIOCARE COLOMBIA || S.A.S
Manufacturer Parent Company (2017)
Danaher Corporation
Source
NIDFSINVIMA
40 more
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