Events

Recall of Foetal Haemoglobin Monoclonal Antibody (HBF-1). 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 Life Technologies 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-2017-RN-01414-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01414-1
  • 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
    Life technologies australia have received four (4) customer complaints worldwide on multiple lots pertaining to poor antibody detection whereby customers reported little to no antibody staining. in the complaints received, customers identified a reduction in the intensity of staining, unequal staining, and in some instances, may have observed a reduction or shift in the positive population peak for foetal haemoglobin. with the use of controls, the end user can identify a product deficiency before diagnostic samples are analysed. failure of the positive controls to perform as expected is a basis for discarding test results and repeating the test.There have been no reports of injuries as a result of this issue.
  • Action
    Life Technologies is advising users to inspect stock and discard any remaining units of the affected lot number. There is unaffected stock available.

Device

Foetal Haemoglobin Monoclonal Antibody (HBF-1). An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Foetal Haemoglobin Monoclonal Antibody (HBF-1). An in vitro diagnostic medical device (IVD) Catalogue Number: MHFH01Lot Number: 1848553AExpiry date: 31 January 2019ARTG Number: 212744
  • Manufacturer
    Life Technologies Australia Pty Ltd

Manufacturer

Life Technologies Australia Pty Ltd