Events

Recall of Immulite 2000, 2000 XPi EBV-EBNA Ig

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens 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-2012-RN-00925-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00925-1
  • 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 has identified that lot to lot variability has resulted in the relative specificity not meeting the product instructions for use (ifu) claims.
  • Action
    Update to IFU claims. This action has been closed-out on 28/04/2016.

Device

Immulite 2000, 2000 XPi EBV-EBNA Ig
  • Model / Serial
    Immulite 2000, 2000 XPi EBV-EBNA IgG Assay; An in vitro diagnostic medical device (IVD)Catalogue Number: L2KEB2Lot Numbers: 215 and above
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA