Recall Z-0159-2016— LifeHealth, LLC
Class II · Terminated
Class II FDA medical device recall by LifeHealth, LLC, initiated 2015-09-16, terminated 2016-03-21. It names one FDA 510(k) clearance: K945240. Product: 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.. Reason: 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..
- Recalling firm
- LifeHealth, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-16
- Terminated
- 2016-03-21
- Firm location
- Roseville, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.