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Beckman Coulter Inc.

526 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
UniCel DxC 680i The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel recall (Z-2074-2011)Beckman Coulter Inc.2011-04-26
UniCel DxC 660i The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel recall (Z-2075-2011)Beckman Coulter Inc.2011-04-26
UniCel DxC 880i The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel recall (Z-2076-2011)Beckman Coulter Inc.2011-04-26
UniCel DxC 800 PRO The UniCel DxC SynchronClinical Systems are fully automated, computer-c recall (Z-2077-2011)Beckman Coulter Inc.2011-04-26
UniCel DxC 800 The UniCel DxC SynchronClinical Systems are fully automated, computer-contr recall (Z-2078-2011)Beckman Coulter Inc.2011-04-26
UniCel DxC 600i The UniCel DxC SynchronClinical Systems are fully automated, computer-cont recall (Z-2079-2011)Beckman Coulter Inc.2011-04-26
UniCel 600 PRO The UniCel DxC SynchronClinical Systems are fully automated, computer-contr recall (Z-2080-2011)Beckman Coulter Inc.2011-04-26
UniCel DxC 600 The UniCel DxC SynchronClinical Systems are fully automated, computer-contr recall (Z-2081-2011)Beckman Coulter Inc.2011-04-26
COULTER LH 500 Series Analyzer Part number: 178832, 178833, 178834 The COULTER LH 500 Anal recall (Z-2042-2011)Beckman Coulter Inc.2011-04-20
COULTER HmX Hematology Analyzer Part number: 6605522, 6605523, 6605524 The COULTER HmX Hem recall (Z-2043-2011)Beckman Coulter Inc.2011-04-20
COULTER HmX Hematology Analyzer with Autoloader Part number: 6605525, 6605526, 6605527 The recall (Z-2044-2011)Beckman Coulter Inc.2011-04-20
IMMAGE Immunochemistry Systems Wash Solution Part Number: 447060 The IMMAGE Immunochemistr recall (Z-2045-2011)Beckman Coulter Inc.2011-04-20
Active Prolactin ELISA, 96 Wells, DSL-10-4500 The DSL-10-4500 Active Prolactin Enzyme-Link recall (Z-2047-2011)Beckman Coulter Inc.2011-04-20
COULTER AC-T 5diff Autoloader Hematology Analyzer, Part Number: 175356, Serial Numbers(s): recall (Z-1979-2011)Beckman Coulter Inc.2011-04-14
UniCel DxH 800 Floor Cabinet Part Number: 723335 The UniCel DxH 800 Analyzer is a quantita recall (Z-1980-2011)Beckman Coulter Inc.2011-04-14
UniCel DxC Clinical Systems with Serial Number less than 3412 Including: UniCel DxC 600 Pa recall (Z-1972-2011)Beckman Coulter Inc.2011-04-13
UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Ana recall (Z-1977-2011)Beckman Coulter Inc.2011-04-13
UniCel DxH 800 Floor Cabinet Part Number: 723335 The UniCel DxH 800 Analyzer is a quantita recall (Z-1978-2011)Beckman Coulter Inc.2011-04-13
Liquid Waste Bottle To store waste material from completed assays. recall (Z-1934-2011)Beckman Coulter Inc.2011-04-12
Access Immunoassay Systems, Part Number 81600N & 81600N. An in vitro diagnostic device use recall (Z-1935-2011)Beckman Coulter Inc.2011-04-12
UniCel DxC 600i Access Immunoassay Systems, Part Number A25656. An in vitro diagnostic dev recall (Z-1936-2011)Beckman Coulter Inc.2011-04-12
SYNCHRON LxI 725 Access Clinical Systems, Part Number: 386200. An in vitro diagnostic devi recall (Z-1937-2011)Beckman Coulter Inc.2011-04-12
Access Total T4 Reagent Kit, Part Number: 33800, Lot Numbers (s): All reagent pack lots Th recall (Z-1949-2011)Beckman Coulter Inc.2011-04-12
Coulter LH750 Analyzer The COULTER LH 750 Hematology Analyzer is a quantitative, automated recall (Z-1953-2011)Beckman Coulter Inc.2011-04-12
Coulter LH780 Analyzer The COULTER LH 750 Hematology Analyzer is a quantitative, automated recall (Z-1954-2011)Beckman Coulter Inc.2011-04-12
Coulter LH500 Series System The COULTER LH 500 Analyzer is a quantitative, automated hemat recall (Z-1955-2011)Beckman Coulter Inc.2011-04-12
Coulter GEN's The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer recall (Z-1956-2011)Beckman Coulter Inc.2011-04-12
UniCel DxI 800 Access Immunoassay Systems; Part Number(s): DxI 800: 973100, DxI 800 Remanu recall (Z-1938-2011)Beckman Coulter Inc.2011-04-11
UniCel DxI 600 Access Immunoassay Systems; Part Number(s): DxI 600: A30260, DxI 600 with s recall (Z-1939-2011)Beckman Coulter Inc.2011-04-11
UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems; Part Number(s): DxC 66 recall (Z-1940-2011)Beckman Coulter Inc.2011-04-11
Access Free T4 Calibrator, Part Number: 33885, Lot Numbers: 014769 The Access Free T4 Cali recall (Z-1945-2011)Beckman Coulter Inc.2011-04-11
Inhibin A ELISA kit, Part Number: DSL-10-28100-4 The Inhibin A ELISA kit is intended for t recall (Z-1925-2011)Beckman Coulter Inc.2011-04-08
Inhibin A ELISA kit, Part Number: DSL-10-28100T-4 The Inhibin A ELISA kit is intended for recall (Z-1926-2011)Beckman Coulter Inc.2011-04-08
CYTO-STAT tetraCHROME" CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number: 6607013 Allows simu recall (Z-1876-2011)Beckman Coulter Inc.2011-04-04
CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number: 6607073. Allows si recall (Z-1877-2011)Beckman Coulter Inc.2011-04-04
Access Immunoassay Systems enhanced AccuTnl Reagent Kit, Part Number: A78803 The Access Ac recall (Z-1883-2011)Beckman Coulter Inc.2011-04-04
Access Thyroglobulin Antibody II, Part Number: A32898 The Access Thyroglobulin Antibody II recall (Z-1818-2011)Beckman Coulter Inc.2011-03-24
SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 RF reagent, when used recall (Z-1743-2011)Beckman Coulter Inc.2011-03-22
Access Total BhCG (BhCG) Assay Part Number 33500 The Access Total BhCG assay is a paramagn recall (Z-1736-2011)Beckman Coulter Inc.2011-03-21
Coulter HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader. Hematology An recall (Z-1730-2011)Beckman Coulter Inc.2011-03-18
Coulter MAXM Hematology Analyzer and MAXM Hematology Analyzer with Autoloader. Hematology recall (Z-1731-2011)Beckman Coulter Inc.2011-03-18
Estrone Radioimmunoassay (RIA) Kit, DSL-8700. Intended for in vitro diagnostic use. recall (Z-1685-2011)Beckman Coulter Inc.2011-03-17
GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron Clinical Sys recall (Z-1619-2011)Beckman Coulter Inc.2011-03-09
Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number recall (Z-0607-2011)Beckman Coulter Inc.2010-12-13
Active I-PTH ELISA, Part Number: DSL-10-8000 The DSL-10-80000 ACTIVE I-PTH Enzyme-Linked I recall (Z-0584-2011)Beckman Coulter Inc.2010-12-09
Active INTACT PTH, Part Number: DSL-8000 The DSL-80000 ACTIVE Intact PTH IRMA Kit provides recall (Z-0585-2011)Beckman Coulter Inc.2010-12-09
Access Immunoassay Systems Estradiol, Part Number: 33540 Intended use: The Access Estradio recall (Z-0448-2011)Beckman Coulter Inc.2010-11-23
Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part nu recall (Z-0431-2011)Beckman Coulter Inc.2010-11-22
Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 The DSL-10 recall (Z-0107-2011)Beckman Coulter Inc.2010-10-20
Access Immunoassay Systems Free T4, Part Number: 33880 recall (Z-2658-2010)Beckman Coulter Inc.2010-10-01
UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software ver recall (Z-2590-2010)Beckman Coulter Inc.2010-09-30
SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920 recall (Z-2653-2010)Beckman Coulter Inc.2010-09-30
Access Immunoassay Systems PROGESTERONE, Part Number: 33550 recall (Z-2620-2010)Beckman Coulter Inc.2010-09-29
Access Immunoassay Systems CORTISOL, Part Number: 33600 recall (Z-2621-2010)Beckman Coulter Inc.2010-09-29
IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600 IGFBP recall (Z-2607-2010)Beckman Coulter Inc.2010-09-28
SYNCHRON Gentamicin (GEN) Reagent GEN reagent, when used in conjunction with SYNCHRON LX S recall (Z-2437-2010)Beckman Coulter Inc.2010-09-20
Unicel Synchron Clinical Systems Closed Tube Aliquotter (CTA) for Synchron LXi 725, Part N recall (Z-2441-2010)Beckman Coulter Inc.2010-09-20
Closed Tube Aliquotter (CTA) for UniCel DxC 600i, Part Number: A25637, Domestic; A25633, I recall (Z-2442-2010)Beckman Coulter Inc.2010-09-20
GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( recall (Z-2388-2010)Beckman Coulter Inc.2010-09-09
SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525 Systems AQUA C recall (Z-2389-2010)Beckman Coulter Inc.2010-09-09
Beckman Coulter Access Thyroglobulin Antibody II Reagent, Part Number: A32898. The Access recall (Z-2355-2010)Beckman Coulter Inc.2010-09-02
COULTER LH 500 Series System recall (Z-2337-2010)Beckman Coulter Inc.2010-09-01
Unicel DxH 800 Coulter Cellular Analysis System recall (Z-2338-2010)Beckman Coulter Inc.2010-09-01
Access Immunoassay Systems AFP QC, Part Number: 33219 The Access AFP QC is intended for mo recall (Z-2208-2010)Beckman Coulter Inc.2010-08-11
IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650 recall (Z-2195-2010)Beckman Coulter Inc.2010-08-10
Access Immunoassay Systems enhanced AccuTnl Reagent Kit; Part Number: A78803 The Access Ac recall (Z-1995-2010)Beckman Coulter Inc.2010-07-12
Unicel DxH 800 Coulter Cellular Analysis System, Part number(s): 629029 recall (Z-1905-2010)Beckman Coulter Inc.2010-06-25
COULTER PrepPlus, Part Number: 286600 recall (Z-1758-2010)Beckman Coulter Inc.2010-06-04
COULTER PrepPlus 2, Part Number: 378600 recall (Z-1759-2010)Beckman Coulter Inc.2010-06-04
UniCel DxH 800 Coulter Cellular Analysis System, Part Number 629029. Beckman Coulter, Inc. recall (Z-1656-2010)Beckman Coulter Inc.2010-05-26
Coulter LH 500 Series System. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hema recall (Z-1657-2010)Beckman Coulter Inc.2010-05-26
Unicel DxH 800 Coulter Cellular Analysis System. Beckman Coulter, Inc. Brea, CA. Quantitat recall (Z-1658-2010)Beckman Coulter Inc.2010-05-26
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc recall (Z-1680-2010)Beckman Coulter Inc.2010-05-26
Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl A recall (Z-1318-2010)Beckman Coulter Inc.2010-04-12
Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell. PN Numbers: A10405 (Uni recall (Z-0863-2010)Beckman Coulter Inc.2010-03-04
Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel Dx recall (Z-0914-2010)Beckman Coulter Inc.2010-03-02
IMMAGE Immunochemistry Systems C-Reactive Protein (CRP) Reagent, Part Number 447280. Inten recall (Z-0921-2010)Beckman Coulter Inc2010-03-02
COULTER LH SlideMaker, LH Barcode Specification, LH SM Intended Use, LH Slide and Sample F recall (Z-0850-2010)Beckman Coulter Inc2010-02-25
GEN*S SlideMaker, Barcode Label Specifications, GEN*S SM Intended Use, GEN*S Slide and Sam recall (Z-0851-2010)Beckman Coulter Inc2010-02-25
UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i S recall (Z-0856-2010)Beckman Coulter Inc.2010-02-25
SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used i recall (Z-2238-2009)Beckman Coulter Inc2009-09-30
Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215. The Access Hybritech fre recall (Z-2220-2009)Beckman Coulter Inc2009-09-16
Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a param recall (Z-1396-2009)Beckman Coulter Inc2009-05-22
Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205 recall (Z-1197-2009)Beckman Coulter Inc2009-04-28
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. recall (Z-0129-2009)Beckman Coulter Inc2009-01-13
Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2 recall (Z-0455-2009)Beckman Coulter Inc2009-01-07
Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41 recall (Z-0454-2009)Beckman Coulter Inc2008-12-16
Synchron Acetaminophen (ACTM) Reagent, Part Number 472169. ACTM Reagent when used in conju recall (Z-2405-2008)Beckman Coulter Inc2008-09-25
Access and Access 2 Immunoassay System recall (Z-2384-2008)Beckman Coulter Inc2008-09-21
SYNCHRON LXi 725 System recall (Z-2385-2008)Beckman Coulter Inc2008-09-21
Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System recall (Z-2386-2008)Beckman Coulter Inc2008-09-21
UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron Access Clinical Syst recall (Z-2387-2008)Beckman Coulter Inc2008-09-21
Access Power Supply Assembly Sled Part Number: A48196/6845C; Component of: Access and Acce recall (Z-1183-2008)Beckman Coulter Inc2008-08-20
Beckman Coulter UniCel Dxl 800 Access Immunoassay System; Part Number: 973100 With: UniCel recall (Z-1184-2008)Beckman Coulter Inc2008-08-20
Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbe recall (Z-1529-2008)Beckman Coulter Inc2008-08-08
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - FC 500 with recall (Z-2016-2008)Beckman Coulter Inc2008-07-11
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - FC 500 120V, recall (Z-2017-2008)Beckman Coulter Inc2008-07-11
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis recall (Z-2018-2008)Beckman Coulter Inc2008-07-11
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis recall (Z-2019-2008)Beckman Coulter Inc2008-07-11
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis recall (Z-2020-2008)Beckman Coulter Inc2008-07-11
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Every clearance here is in the API, with alerts when new ones post.