Safety Alert for I-stat 1 Analyzer system - G3+ Cartridge

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Abbott Point of Care Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: abbott i-stat 1 analyzer system - g3+ cartridge 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.


  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott I-stat 1 Analyzer system - G3+ Cartridge
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source