8 results
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31ms
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Sources: EU EUDAMED, US FDA
IRMA TRUPOINT BLOOD ANALYZER
FDA Adverse Event
Malfunction
·LIFEHEALTH, LLC·Product code CHL·June 6, 2017
LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, pCO2, pH, iCa, Na, K and Cl.
FDA Recall
Terminated
·LifeHealth, LLC·Product code CHL·April 29, 2015
BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint Blood Analysis System.
FDA Recall
Terminated
·LifeHealth, LLC·Product code CHL·September 16, 2015
CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint Blood Analysis System.
FDA Recall
Terminated
·LifeHealth, LLC·Product code CHL·September 16, 2015
LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, pCO2, pH, iCa, Na, K and Cl.
FDA Enforcement
Class II
·Terminated·LifeHealth, LLC·July 8, 2015
BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
FDA Enforcement
Class II
·Terminated·LifeHealth, LLC·November 4, 2015
CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
FDA Enforcement
Class II
·Terminated·LifeHealth, LLC·November 4, 2015
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