Events

Recall of GEM PREMIER 4000 SYSTEM - INSTRUMENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INSTRUMENTATION LABORATORY CO..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50356
  • Event Risk Class
    II
  • Event Initiated Date
    2011-06-06
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Rare occurrences of falsely lowered k+ results (potential negative bias of 0.6 to 1.2 mmol/l) can occur during cartridge life on patient blood analysis leading to erroneous results with potentially severe impact to patient treatment.

Device

GEM PREMIER 4000 SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 00025000000 (Lot serial: SN 06050100 to 11064853)
  • Product Description
    GEM Premier 4000 System
  • Manufacturer
    INSTRUMENTATION LABORATORY CO.

Manufacturer

INSTRUMENTATION LABORATORY CO.
  • Manufacturer Address
    BEDFORD
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    HC