Events

Recall of LIQUICHEK BLOOD GAS PLUS E CONTROL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIO-RAD LABORATORIES (CANADA) LTD..

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
    24205
  • Event Risk Class
    II
  • Event Initiated Date
    2012-06-12
  • 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
    The package insert blood gas plus e control levels 123 and trilevel minipak for the mentionned lots listed incorrect means and values ranges for several analytes and methods. the package insert has since been revised to contain the correct values.

Device

LIQUICHEK BLOOD GAS PLUS E CONTROL
  • Model / Serial
    Model Catalog: 577 (Lot serial: 22201); Model Catalog: 576 (Lot serial: 22202); Model Catalog: 577 (Lot serial: 22202); Model Catalog: 576 (Lot serial: 22201); Model Catalog: 578 (Lot serial: 22203); Model Catalog: 575X (Lot serial: 22200)
  • Product Description
    Liquichek Blood Gas Plus E Ctl Niveaux123 et Trilevel MiniPak
  • Manufacturer
    BIO-RAD LABORATORIES (CANADA) LTD.

Manufacturer

BIO-RAD LABORATORIES (CANADA) LTD.