3,794 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COBAS 311
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code PDJ·October 10, 2014
A1CNOW+ PROFESSIONAL TEST KIT
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code PDJ·June 11, 2021
DIMENSION RXL MAX WITH HM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code PDJ·November 17, 2014
DIMENSION EXL 200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code PDJ·November 14, 2014
A1CNOW+ PROFESSIONAL TEST KIT
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code PDJ·June 30, 2021
HEMOGLOBIN A1C
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code PDJ·April 29, 2022
ALINITY C HEMOGLOBIN A1C REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code PDJ·June 28, 2022
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·April 13, 2022
A1CNOW+ PROFESSIONAL TEST KIT
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code PDJ·June 30, 2021
A1CNOW+ PROFESSIONAL TEST KIT
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code PDJ·September 17, 2024
G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·July 8, 2024
A1CNOW SELF CHECK
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code PDJ·July 3, 2024
G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·July 24, 2024
HLC-723 G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·July 26, 2024
HLC-723 G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·April 25, 2022
ALINITY C HEMOGLOBIN A1C REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code PDJ·June 28, 2022
G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·June 5, 2024
HLC-723 G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·July 1, 2024
A1CNOW SELF CHECK CHEMISTRY KIT
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code PDJ·September 20, 2024
HLC-723 G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·April 15, 2024