LifeHealth, LLC: Medical Device Recall in 2015 - (Recall #: Z-0159-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 16, 2015

Date Posted: November 4, 2015

Recall Number: Z-0159-2016

Event ID: 72305

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.

Status: Terminated

Product Quantity: 4659 boxes of 25. (116475 cartridges)

Code Information:

ASBEZ ASCXE ASEMB ASHWQ ASJMY ASLGI ASMXR ASOQO ASRXC ASTQR ASWZI

Distribution Pattern:

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, IRELAND, ITALY, JAMAICA, JAPAN, MOROCCO, NETHERLANDS, NORWAY, PERU, PORTUGAL, SOUTH AFRICA, SOUTH KOREA, SPAIN, TAIWAN, TUNISIA, TURKEY, UNITED ARAB EMIRATES, VIETNAM.

Voluntary or Mandated:

Voluntary: Firm initiated