Home / Recalls / Abbott Point Of Care Inc. / Z-1306-2014

Z-1306-2014 Class II Terminated

Recalled by Abbott Point Of Care Inc. — Princeton, NJ

Recall Details

Product Type
Devices
Report Date
April 2, 2014
Initiation Date
January 1, 2014
Termination Date
October 20, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
48, 450 US, 1400 OUS (49,850 catridges)

Product Description

i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.

Reason for Recall

Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Canada.

Code Information

List number 03P78-25 :Lot number N13183

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