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Lifehealth

Last updated May 30, 2026

Information

Device	Model / Reference	Registries	Class	Status
CR Cartridge	074220	FDA UDI	Class II	Active
LA Cartridge	078770	FDA UDI	Class I	Active
BG Cartridge	049110	FDA UDI	Class II	Active
H4 Cartridge	054330	FDA UDI	Class II	Active
CC Cartridge	049330	FDA UDI	Class II	Active
Creatinine Control Kit	074446	FDA UDI	Class I	Active
H3 Cartridge	049220	FDA UDI	Class II	Active
LA Cartridge	078770	FDA UDI	Class I	Active
CC Cartridge	049330	FDA UDI	Class II	Active
GL Cartridge	067660	FDA UDI	Class II	Active
BG Cartridge	049110	FDA UDI	Class II	Active
H3 Cartridge	049220	FDA UDI	Class II	Active
CR Cartridge	074220	FDA UDI	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 16, 2015	Z-0160-2016	—	terminated	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.
Sep 16, 2015	Z-0159-2016	—	terminated	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.
Apr 29, 2015	Z-1919-2015	—	terminated	The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.