Events

Recall of Calibrator BRAHMS Free beta-hCG KRYPTOR CAL. 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.

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-2014-RN-00155-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00155-1
  • 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
    Thermo fisher scientific would like to inform that the use of calibrator brahms free beta-hcg kryptor cal may result in a decreased free beta-hcg concentration for brahms gm kryptor qc as well as for patient samples by approximately 4%. this may lead to incorrect risk estimation of chromosomal anomaly of the foetus.
  • Action
    Thermo Fisher Scientific is advising users to stop use of the affected lot number. The affected lot will be replaces by a previous calibrator which may have a shorter expiry date. Thermo Fisher is recommending that results generated with the affected calibrator are re-evaluated in the context of other laboratory and clinical parameters and retest if required.

Device

Calibrator BRAHMS Free beta-hCG KRYPTOR CAL. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Calibrator BRAHMS Free beta-hCG KRYPTOR CAL. An in vitro diagnostic medical device (IVD)Lot Number: 09045Expiry Date: 16 October 2014Kit Reference Number: CDB80991
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific