Events

Safety Alert for GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Instrumentation Laboratory Company.

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
    2011-08-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110803.html
  • 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
    Fda class i recall: gem premier 4000 pak cartridges for use on the gem premier 4000 system it has come to our attention that the u.S. food and drug administration (fda) has issued an class i recall to remind healthcare providers and patients that gem premier 4000 pak cartridges for use on the gem premier 4000 portable critical care system, which is manufactured by instrumentation laboratory company, may give inaccurate results. potassium test results on the gem premier 4000 are too low when compared to a reference analyzer; with biases exceeding the allowable error claim of plus or minus 0.5 mmol/l by as much as 2.0 mmol/l. use of this product may lead to inappropriate patient treatment and may cause serious adverse health consequences, including death. to avoid this, the manufacturer recommended customers to follow the instructions to disable the potassium test to eliminate the potential of erroneous result reporting. according to the local supplier, hong kong is affected. the local supplier has contacted the affected customers for corrective actions for details, please refer to the following link: http://www.Fda.Gov/safety/medwatch/safetyinformation/ safetyalertsforhumanmedicalproducts/ucm266113.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System

Manufacturer

Instrumentation Laboratory Company