FDAApril 29, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.
What to do
FDA enforcement status: Terminated
Brands named
lifehealth
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACC 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.2015-09-16
- FDABG 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.2015-09-16
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →