Events

Recall of Life Technologies Dynabeads HLA Class 2

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Life Technologies AS.

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
    16519
  • Event Initiated Date
    2014-04-10
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Life Science NZ Ltd, 17 Maritime Rce, Birkenhead, AUCKLAND
  • Reason
    The manufacturer of dynabeads hla class ii, life technologies as, advises that specific lots have decreased antibody performance and may not isolate sufficient levels of hla class ii cells for further testing.
  • Action
    Product to be destroyed

Device

Life Technologies Dynabeads HLA Class 2
  • Model / Serial
    Model: Catalogue Number: 21004D, Affected: Lot Numbers: 135384110 (Exp.D. 2014-09), 142281200 (Exp.D. 2015-02)
  • Manufacturer
    Life Technologies AS

Manufacturer

Life Technologies AS