Events

Recall of Dynabeads HLA (Human Leucocyte Antigen) Class II (an in vitro diagnostic medical device)(reagent used for the isolation of HLA Class II+ cells from human peripheral blood)

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-2014-RN-00416-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00416-1
  • 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 manufacturer of dynabeads hla class ii, life technologies as, advises that the listed lots have decreased antibody performance and may not isolate sufficient levels of hla class ii cells required for further testing. lot 142281200 is still within specification, however testing has indicated that it might lose reactivity prior to its expiry date.
  • Action
    Life Technologies is requesting their customers to inspect their stock and dispose of all units from the affected lots. Lot 142281200 can continue to be used until replacement stock is available.

Device

Dynabeads HLA (Human Leucocyte Antigen) Class II (an in vitro diagnostic medical device)(reagent ...
  • Model / Serial
    Dynabeads HLA (Human Leucocyte Antigen) Class II (an in vitro diagnostic medical device)(reagent used for the isolation of HLA Class II+ cells from human peripheral blood)Catalogue Number: 21004DLot Numbers: 135384110 (Expiry Date: 09/2014)142281200 (Expiry Date: 02/2015)ARTG Number: 212748
  • Manufacturer
    Life Technologies Australia Pty Ltd

Manufacturer

Life Technologies Australia Pty Ltd