48 results
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52ms
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Sources: EU EUDAMED, US FDA
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
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
OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER (AU481-03 ISE)
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMAK.K.·Product code JJE·October 19, 2011
OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER (AU481-03 ISE)
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMAK.K.·Product code JJE·October 19, 2011
COULTER® LH 780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GKZ·November 21, 2012
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 Recall
Terminated
·Beckman Coulter Inc.·Product code KQO·October 18, 2018
LIPASE
FDA Adverse Event
Malfunction
·BECKMAN COULTER BIOMEDICAL LIMITED·Product code CDT·June 6, 2011
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·April 25, 2012
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 17, 2011
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 Recall
Terminated
·Beckman Coulter Inc.·Product code OYE·January 29, 2018
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code LOM·March 29, 2012
Beckman Coulter Ireland Inc.
Authorized representative
🇮🇪 Ireland·3 Manufacturers·1177 Devices
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·March 8, 2012
ID NOW COVID-19 ASSAY
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·July 1, 2021
ACCESS® 2 IMMUNOASSAY SYSTEM, SINGLE SYSTEM SG
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·October 21, 2011
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 17, 2011
SYNCHRON LXI 725 SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·August 9, 2012
SWAN-GANZ PACING CATHETER
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES, PR·Product code DQE·September 13, 2010
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·February 16, 2012
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·February 16, 2012