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Beckman Coulter Inc.

526 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
ICON 25 hCG test kit. recall (Z-0374-04)Beckman Coulter Inc2004-01-29
Coulter DNA Prep Reagents Kit Part 6607055 recall (Z-0136-04)Beckman Coulter Inc2003-11-19
Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron recall (Z-0096-04)Beckman Coulter Inc2003-11-06
Synchron CX4, CX5 and CX9 Pro Systems. recall (Z-0067-04)Beckman Coulter Inc2003-10-24
Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604 recall (Z-0039-04)Beckman Coulter Inc2003-10-15
Coulter AcT 5diff Cap Pierce Hematology Analyzers Part Numbers: 6605641, 6605705 recall (Z-0040-04)Beckman Coulter Inc2003-10-15
Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent recall (Z-0046-04)Beckman Coulter Inc2003-10-15
Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29 recall (Z-1148-03)Beckman Coulter Inc2003-08-21
Synchron LX Systems Primary Tube Sample Template (a piece of ''labeling'' for use with the recall (Z-1077-03)Beckman Coulter Inc2003-08-06
Coulter Clone B6-FITC Reagent recall (Z-1071-03)Beckman Coulter Inc2003-07-30
ACCESS Estradiol Reagent Test System recall (Z-0872-03)Beckman Coulter Inc2003-05-29
COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use recall (Z-0805-03)Beckman Coulter Inc2003-05-09
ICON DS hCG, an in-vitro diagnostic. Part number 44025. recall (Z-0706-03)Beckman Coulter Inc2003-04-02
Access 2 Immunoassay System recall (Z-0692-03)Beckman Coulter Inc2003-03-29
Access 2 immunoassay side of LXi 725 recall (Z-0693-03)Beckman Coulter Inc2003-03-29
LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645 recall (Z-0669-03)Beckman Coulter Inc2003-03-21
Access and Access 2 Immunoassay Systems 862.2160 Discrete photometric chemistry analyzer f recall (Z-0619-03)Beckman Coulter Inc2003-03-06
AcT 5 diff Cap Pierce Hematology Analyzer 864.5220 Automated differential cell counter recall (Z-0570-03)Beckman Coulter Inc2003-02-25
Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell recall (Z-0571-03)Beckman Coulter Inc2003-02-25
Coulter LH 700 Series Hematology Analyzers recall (Z-0541-03)Beckman Coulter Inc2003-02-05
SYNCHRON LX20 AND LX20 Pro recall (Z-0545-03)Beckman Coulter Inc2003-02-05
Access Progesterone Assay, Part number 33550. recall (Z-0494-03)Beckman Coulter Inc2003-01-30
COULTER LH 700 Series Hematology Analyzers recall (Z-0415-03)Beckman Coulter Inc2003-01-09
COULTER LH 700 Series Hematology Analyzers recall (Z-0416-03)Beckman Coulter Inc2003-01-09
COULTER LH 700 Series Hematology Analyzers recall (Z-0417-03)Beckman Coulter Inc2003-01-09
COULTER LH 700 Series Hematology Analyzers recall (Z-0418-03)Beckman Coulter Inc2003-01-09
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Every clearance here is in the API, with alerts when new ones post.