19 results
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46ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Malfunction
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SYSMEX XE-2100
FDA Adverse Event
Malfunction
·SYSMEX AMERICA, INC·Product code GKZ·February 23, 2010
SYSMEX WORK AREA MANAGEMENT SYSTEM (MDDS)
FDA Adverse Event
Malfunction
·SYSMEX AMERICA INC.·Product code OUG·September 11, 2015
SYSMEX WORK AREA MANAGER (WAM)
FDA Adverse Event
Malfunction
·SYSMEX AMERICA, INC.·Product code OUG·March 28, 2012
SYSMEX WORK AREA MANAGER SYSTEM
FDA Adverse Event
Malfunction
·SYSMEX AMERICA INC.·Product code OUG·September 10, 2015
SYSMEX XT
FDA Adverse Event
Malfunction
·SYSMEX AMERICA, INC.·Product code GKL·April 10, 2007
UDM-IPU
FDA Adverse Event
Malfunction
·SYSMEX AMERICA INC.·Product code OUG·July 1, 2024
SYSMEX XN-10
FDA Adverse Event
Malfunction
·SYSMEX AMERICA INC.·Product code GKZ·September 22, 2014
CARESPHERE WORKFLOW SOLUTION
FDA Adverse Event
Malfunction
·SYSMEX AMERICA INC.·Product code JQP·February 9, 2023
*
FDA Adverse Event
Malfunction
·SYSMEX AMERICA, INC.·Product code GKZ·March 20, 2009
SYSMEX
FDA Adverse Event
Malfunction
·SYSMEX AMERICA, INC.·Product code GKZ·March 15, 2016
SYSMEX WORK AREA MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·SYSMEX AMERICA INC.·Product code OUG·January 29, 2016
SYSMEX HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·SYSMEX AMERICA, INC.·Product code GKZ·November 3, 2023
BD VACUTAINER® MICROBIOLOGY C&S TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 18, 2018
BD VACUTAINER® URINE COLLECTION CUP
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JTW·June 6, 2018
BD VACUTAINER® URINE TUBE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·May 2, 2018
SYSMEX POCH-100I ANALYZER
FDA Adverse Event
Malfunction
·SYSMEX CORP·Product code GKL·April 3, 2013
SYSMEX CA-650 COAGULATION ANALYZER
FDA Adverse Event
Malfunction
·SYSMEX CORP.·Product code GKP·December 8, 2014
SYSMEX TS-10
FDA Adverse Event
Malfunction
·SYSMEX RA CO.,LTD. MAIN PLANT·Product code LXG·December 17, 2025
AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60
FDA Adverse Event
Malfunction
·CELLAVISION AB·Product code JOY·October 8, 2025