646 results
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47ms
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Sources: EU EUDAMED, US FDA
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Beckman Coulter Flow-Count Fluorospheres - Part Number 7547053, Beckman Coulter, Inc., Fullerton, CA 92835
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·May 21, 2007
UniCel DxC 600 Part Number: A10405, Beckman Coulter, Inc.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JJE·April 5, 2007
Synchron LX20 PRO, Part Number 476100, Beckman Coulter, Inc.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JJE·April 5, 2007
Synchron LXi 725, Part Number A08357, Beckman Coulter, Inc.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JJE·April 5, 2007
UniCel DxC 800 Part Number: A10411, Beckman Coulter, Inc.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JJE·April 5, 2007
UniCel DxC 600i, Part Numbers: A25638, A25639, Beckman Coulter, Inc.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JJE·April 5, 2007
UniCel DxC 800 PRO Part Number: A10407, Beckman Coulter, Inc.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JJE·April 5, 2007
UniCel DxC 600 PRO Part Number: A10400, Beckman Coulter, Inc.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JJE·April 5, 2007
Synchron LX20 Clinical Chemistry System, Part Numbers: 466200,473032, Beckman Coulter, Inc.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JJE·April 5, 2007
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·December 8, 2009
Coulter LH 500 Series System. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer and leukocyte differential cell counter for in vitro diagnostic use in clinical laboratories.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·February 4, 2010
IMMAGE Immunochemistry Systems Wash Solution Part Number: 447060 The IMMAGE Immunochemistry Systems Wash Solution is intended for use with IMMAGE Immunochemistry Systems and reagents for the quantitative determinations of components in biological fluids. The Beckman Coulter IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top analyzer designed for the in vitro quantitation of biological fluid components and therapeutic drugs. The system methodologies are rate turbidimetry and rate nephelometry.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code LDT·August 24, 2010
Unicel DxH 800 Coulter Cellular Analysis System. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer and for in vitro diagnostic use in screening patient populations found in clinical laboratories.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·February 4, 2010
UniCel DxH 800 Coulter Cellular Analysis System, Part Number 629029. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·March 2, 2010
IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code DHR·January 27, 2012
Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205. The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code LTJ·January 8, 2008
BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500 Series Cleaner CLEANER, COULTER CLENZ DXH 500SERIES (0.5L/KT) Catalog # B36868
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code GGK·May 25, 2022
UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Beckman Coulter, Inc, Brea CA 92822
FDA Recall
Terminated
·Beckman Coulter Inc·Product code MMI·July 19, 2007
SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code KHP·May 28, 2013
iChemVELOCITY Urine Chemistry System-
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code KQO·March 30, 2020