17 results
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53ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Adverse Event
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HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM - ACT-LR CUVETTES
FDA Adverse Event
Malfunction
·ACCRIVA DIAGNOSTICS, INC.·Product code JBP·November 4, 2025
HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM - HEMOCHRON SIGNATURE ELITE INSTR
FDA Adverse Event
Death
·ACCRIVA DIAGNOSTICS, INC.·Product code JPA·July 1, 2025
HEMOCHRON ACTIVATED CLOTTING TIME PLUS (ACT+) TEST
FDA Adverse Event
Death
·ACCRIVA DIAGNOSTICS, INC.·Product code JBP·September 24, 2024
HEMOCHRON ACT-LR TEST
FDA Adverse Event
Death
·ACCRIVA DIAGNOSTICS, INC.·Product code JBP·May 23, 2022
HEMOCHRON¿ WHOLE BLOOD MICROCOAGULATION SYSTEM-HEMOCHRON SIGNATURE ELITE INSTR
FDA Adverse Event
Malfunction
·ACCRIVA DIAGNOSTICS, INC.·Product code JPA·October 3, 2025
ACT-LR CUVETTES HEMOCHRON ELITE LOW RANGE ACT
FDA Adverse Event
ACCRIVA DIAGNOSTICS, INC.·Product code JPA·August 26, 2021
HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM
FDA Adverse Event
Injury
·ACCRIVA DIAGNOSTICS, INC.·Product code JPA·March 26, 2024
HEMOCHRON¿ WHOLE BLOOD MICROCOAGULATION SYSTEM - HEMOCHRON SIGNATURE ELITE INSTR
FDA Adverse Event
Death
·ACCRIVA DIAGNOSTICS, INC.·Product code JPA·April 25, 2023
HEMOCHRON SIGNATURE ELITE
FDA Adverse Event
Malfunction
·ACCRIVA DIAGNOSTICS, INC./WERFEN·Product code JPA·April 23, 2025
HEMOCHRON SIGNATURE ELITE WHOLE BLOOD MICROCOAGULATION SYSTEM
FDA Adverse Event
Malfunction
·ACCRIVA DIAGNOSTICS HOLDINGS, INC.·Product code JPA·May 1, 2020
AVOXIMETER WHOLE BLOOD OXIMETER
FDA Adverse Event
Malfunction
·ACCRIVA DIAGNOSTICS HOLDINGS, INC.·Product code DQA·April 20, 2020
AVOXIMETER WHOLE BLOOD OXIMETER
FDA Adverse Event
Malfunction
·ACCRIVA DIAGNOSTICS HOLDINGS, INC.·Product code DQA·May 2, 2019
HEMOCHRON SIGNATURE ELITE
FDA Adverse Event
Malfunction
·WERFEN, S.A. / ACCRIVA DIAGNOSTICS, INC.·Product code JPA·November 12, 2025
VERIFYNOW
FDA Adverse Event
Injury
·WERFEN COMPANY/ACCRIVA DIAGNOSTIC, INC.·Product code JOZ·December 28, 2018
HEMOCHRON
FDA Adverse Event
Malfunction
·ACCRIVA DIAGNOSTICS INC., DBA ITC, DBA ACCUMETRICS·Product code JPA·September 18, 2015
ACT+ CUVETTE
FDA Adverse Event
ACCRIVA DIAGNOSTICS INC., DBA ITC, DBA ACCUMETRICS·Product code JBP·June 1, 2015
HEMOCHRON SIGNATURE ELITE
FDA Adverse Event
Malfunction
·ACCRIVA DIAGNOSTIC INC., DBA INC, DBA ACCUMETRICS·Product code JPA·February 12, 2018