Health Canada has issued a medical device safety alert concerning I-stat 1 Analyzer system - G3+ Cartridge, manufactured by Abbott Point of Care Inc. The affected model number is 03P78-25, and the affected lot number is N13183.
The manufacturer has determined that I-stat G3+ cartridges from cartridge lot number N13183 have the potential to exhibit incorrectly elevated partial pressure of carbon dioxide (PCO2) and depressed pH results. The PCO2 results can be elevated by 10 to 25 mmHg while the pH results can be depressed by 0.10 to 0.15.
All other G3+ cartridge lots are unaffected by this issue.
For details, please visit the following Health Canada website:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/38453r-eng.php
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 21 March 2014