Events

Recall of SYNCHRON Systems Glucose (GLU) cartridge Reagent. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Beckman Coulter Australia Pty 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
    RC-2012-RN-01268-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-12-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01268-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Update to previous recall for product correction (tga ref: rc-2010-rn-00834-3). cartridge glucose on unicel dxc and synchron lx instruments may give falsely high results for moderately haemolysied samples.
  • Action
    Beckman Coulter is providing updated Glucose interference tables for users to follow.

Device

SYNCHRON Systems Glucose (GLU) cartridge Reagent. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    SYNCHRON Systems Glucose (GLU) cartridge Reagent. An in vitro diagnostic medical device (IVD)All Lot numbersReference Number: 442640
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd