9,796 results
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51ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELECSYS CMV IGM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFZ·October 15, 2025
CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFZ·September 7, 2018
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LOL·May 25, 2011
VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HAV IGM REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LOL·December 13, 2011
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LOL·July 10, 2012
ELECSYS TOXO IGM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LGD·November 22, 2023
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
FDA 510(k)
FDA Class 2
·Immunology
Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
FDA 510(k)
FDA Class 2
·Immunology
ADVIA CENTAUR HAV IGM ASSAY
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code LOL·October 30, 2008
IMMULITE 2000 RUBELLA IGM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code LFX·August 21, 2012
AXSYM TOXO IGM
FDA Adverse Event
Other
·ABBOTT LABORATORIES·Product code LGD·May 21, 2004
ANALYTICAL P MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·March 11, 2010
ARCHITECT HAVAB IGM REAGENT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INT'L, LTD·Product code LOL·October 5, 2010
ARCHITECT TOXO IGM
FDA Adverse Event
Injury
·ABBOTT GERMANY·Product code LOL·July 28, 2011
IMMULITE 2000 CMV IGM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code LKQ·October 25, 2016
ELECSYS ANTI-HBC IGM ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS GMBH·Product code LOM·December 4, 2024
ELECSYS ANTI-HBC IGM ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS GMBH·Product code LOM·December 4, 2024
IMMULITE 2000 CMV IGM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code LKQ·September 8, 2016
IMMULITE 2000 XPI RUBELLA IGM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code LFX·September 1, 2016
IMMULITE 2000 RUBELLA IGM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED·Product code LFX·September 2, 2016