Events

Recall of MAS chemTRAK – H Level 1 Control. 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 Thermo Fisher Scientific 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-2018-RN-00596-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-05-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00596-1
  • 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
    The control's open-vial stability claim for all constituents is "once opened, vials of chemtrak - h are stable for 14 days when stores tightly capped at 2-8deg c". the manufacturer has confirmed that one constituent of the control, glucose, does not meet this stability claim as the recovery of this constituent trends down prior to the stated open-vial usage. the open-vial stability claim of 14 days remains unchanged for the other glucose levels, chu20022a and chu20023a.
  • Action
    Thermo Fisher are advising customers to continue to use Level 1 of the chemTRAK control after the initial thaw for a period of 5 days and discard the control after this period.

Device

MAS chemTRAK – H Level 1 Control. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    MAS chemTRAK – H Level 1 Control. An in vitro diagnostic medical device (IVD). Catalogue Number: CHU-1Lot Number: CHU20021AARTG Number: 192625(Thermo Fisher Scientific Australia Pty Ltd - Multiple clinical chemistry constituent IVDs)
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd