Abbott Point Of Care Inc.: Medical Device Recall in 2014 - (Recall #: Z-1306-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
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.

Product Classification:

Class II

Date Initiated: January 1, 2014
Date Posted: April 2, 2014
Recall Number: Z-1306-2014
Event ID: 67513
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.

Status: Terminated
Product Quantity: 48, 450 US, 1400 OUS (49,850 catridges)
Code Information:

List number 03P78-25 :Lot number N13183

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated