9,796 results · 37ms · Sources: EU EUDAMED, US FDA

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ALINITY I CMV IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·April 23, 2024

SARS-COV-2 IGM

FDA Adverse Event
Malfunction ·ABBOTT IRELAND·Product code QKO·February 8, 2021

HSV2 IGM ANTIBODY TEST

FDA Adverse Event
Malfunction ·UNKNOWN·Product code MYF·February 13, 2025

ADVIA CENTAUR XP HAV IGM ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LOL·February 10, 2012

ELECSYS 2010 DISK IMMUNOCHEMISTRY ANALYZER

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·January 16, 2007

ELECSYS TOXO IGM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LGD·June 17, 2022

ELECSYS TOXO IGM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LGD·March 6, 2023

ELECSYS TOXO IGM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LGD·April 10, 2023

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LOM·August 7, 2017

ADVIA CENTAUR XP TOXOPLASMA M (TOXO M)

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·November 6, 2013

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LOL·February 22, 2012

VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LOL·January 13, 2011

ELECSYS TOXO IGM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LGD·April 21, 2025

COBAS 6000 C (501) MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 18, 2021

COBAS E 801 ANALYTICAL UNIT

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·August 7, 2023

CAPTURE-R READY-SCREEN (I AND II)

FDA Adverse Event
Malfunction ·IMMUCOR, INC.·Product code KSZ·June 8, 2013

ADVIA CENTAUR HAV IGM ASSAY

FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LOL·May 16, 2011

ARCHITECT I2000SR ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·July 24, 2008

ABBOTT AXSYM SYSTEM

FDA Adverse Event
Other ·ABBOTT MANUFACTURING, INC.·Product code JHI·August 12, 2005

IMMULITE 2000

FDA Adverse Event
Malfunction ·SIEMENS HEALTCHCARE DIAGNOSTICS INC·Product code JJQ·October 14, 2013