Events

Recall of IMMULITE 2000 and IMMULITE 2000 XPi

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Ltd Diagnostics Division.

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-01238-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01238-1
  • 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
    In december 2013, siemens healthcare diagnostics issued urgent recall for product correction (tga ref. rc-2014-rn-00002-1) for immulite 2000/immulite 2000 xpi androstenedione due to an observed over-recovery. during efforts to restore performance of the androstenedione assay it was confirmed that the issue noted in december 2013 was not limited to samples >5.5 ng/ml (>19.2 nmol/l). please refer to figures 1 and 2 for more information. the root cause of the over-recovery is related to the variability of a critical raw material.
  • Action
    Siemens is requesting their customers to discard the affected lot of IMMULITE 2000/IMMULITE 2000 XPi Androstenedione. A laboratory look back is recommended for any existing androstenedione sample(s) with values generated using the affected reagent lots during the period of time within sample stability labelling, and retesting using an alternate method. This action has been closed-out on 16/05/2017.

Device

IMMULITE 2000 and IMMULITE 2000 XPi
  • Model / Serial
    IMMULITE 2000 and IMMULITE 2000 XPi Catalogue number: SMN 10381188 Lot number: 314-323ARTG number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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