759 results
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37ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·July 10, 2019
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and in selective electrode.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·May 1, 2013
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
Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·October 14, 2015
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
AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·April 18, 2018
Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·September 9, 2015
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