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