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Z-0160-2016 Class II Terminated

Recalled by LifeHealth, LLC — Roseville, MN

FDA device recall Z-0160-2016 was initiated by LifeHealth, LLC on September 16, 2015 and is designated Class II. 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… The recall status is terminated (terminated March 21, 2016). Affected quantity: 1735 boxes of 25. (43375 Cartridges).

Recall Details

Product Type: Devices
Report Date: November 4, 2015
Initiation Date: September 16, 2015
Termination Date: March 21, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1735 boxes of 25. (43375 Cartridges)

Product Description

BG 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.

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.

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.

Code Information

EOSCU EOTUZ EOVMW EOYUL EPANW EPCED EPDVM EPFOJ EPIXX EPKOJ EPNXA