Events

Recall of B.R.A.H.M.S Free BhCG Kryptor Kit. 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-2016-RN-00223-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00223-1
  • 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 has confirmed that the affected lots observe an overestimation of approximately 10% of free bhcg concentration in diluted samples or controls. undiluted samples and controls are not affected by the issue.The dilution of samples may lead to incorrect risk estimation for foetal chromosomal abnormalities. a patient may be considered at higher risk for trisomy 21 or at lower risk for trisomy 13/18.
  • Action
    ThermoFisher Scientific is advising users that the affected lot can continue to be used for undiluted samples only. The affected lot should be discarded once the replacement product has been provided. This action has been closed-out on 09/05/2017

Device

B.R.A.H.M.S Free BhCG Kryptor Kit. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    B.R.A.H.M.S Free BhCG Kryptor Kit. An in vitro diagnostic medical device (IVD)Kit Reference Number: 809.075Lot Numbers: 09075 and 09073 ARTG Number: 199700
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific