LifeHealth Recalls
3 recalls on record · July 8, 2015 to November 4, 2015 · Medical Devices
November 4, 2015Medical DevicesFDA
LifeHealth, LLC recalls BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro dia
Hazard: May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood.
November 4, 2015Medical DevicesFDA
LifeHealth, LLC recalls CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disposable, in vitro di
Hazard: May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood.
July 8, 2015Medical DevicesFDA
LifeHealth, LLC recalls LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of vari
Hazard: The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.