LifeHealth, LLC recalls CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disposable, in vitro di…

Recall date

September 16, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0159-2016

FDA classification

Class II

Brand / firm

LifeHealth, LLC

Sold / distributed

US: Nationwide (AL, AR, CA, CO, FL, IL, IN, IA, KS, KY, MD, MA,MI, MN, MS, MO, NE, NJ, NY,NC, OH, OK, PA, TN, TX, VA) OUS: ALBANIA, BELGIUM, BOLIVIA, CANADA, CHILE, CHINA, DENMARK. DOMINICAN REPUBLIC, ECUADOR, EGYPT, ENGLAND, ESTONIA, PHILIPPINES, FRANCE, GERMANY, GREECE, ICELAND, INDONESIA, IRELAN…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.