3,794 results · 28ms · Sources: EU EUDAMED, 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