772 results · 23ms · Sources: EU EUDAMED, US FDA

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UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·January 21, 2011

ADVIA CENTAUR RUBELLA G (RUB G) ASSAY

FDA Adverse Event
Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LFX·February 22, 2010

ACCU-CHEK ® INFORM II TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 26, 2020

ACCU-CHEK ® INFORM II TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 26, 2020

COBAS B 121

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code CHL·July 16, 2014

VITROS CHEMISTRY PRODUCTS VALP REAGENT

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·October 11, 2012

VITROS CHEMISTRY PRODUCTS VALP REAGENT

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·October 11, 2012

VITROS CHEMISTRY PRODUCTS VALP REAGENT

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·October 11, 2012

VITROS CHEMISTRY PRODUCTS VALP REAGENT

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·October 11, 2012

ELECSYS VITAMIN D TOTAL III

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code MRG·March 18, 2026

AIA-360

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code KHO·July 2, 2019

COBAS E 411 IMMUNOASSAY ANALYZER

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 23, 2020

VITROS XT 7600 INTEGRATED SYSTEM

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·May 20, 2024

ELECSYS TOTAL PSA

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code MTF·March 16, 2023

COBAS 6000 C501 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code CJY·January 19, 2010

VITROS XT 7600 INTEGRATED SYSTEM

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·January 17, 2024

DIMENSION EXL WITH LM

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·May 17, 2016

COBAS 6000 E 601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 29, 2020

ALINITY I PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code JJE·July 26, 2021

COBAS E 411 IMMUNOASSAY ANALYZER

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 29, 2021