19 results · 46ms · Sources: EU EUDAMED, US FDA

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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

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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