Events

Recall of IMMULITE/IMMULITE 1000 IMMULITE 2000/IMMULITE 2000 XPi Assays. 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 Siemens Healthcare 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-01516-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01516-1
  • 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
    Siemens healthcare has confirmed through internal investigation that certain immulite/immulite 1000/immulite 2000/immulite 2000 xpi assays are susceptible to biotin interference. this occurs when biotin present in patient samples interferes with the biotin-streptavidin assay architecture on the immulite platform. biotin interference has the potential to bias analytical results of the affected assays. the instructions for use (ifu) currently do not list biotin as a potential interferant.Concentrations of biotin above the determined concentration can potentially result in interference greater than 10%, leading to either falsely elevated or falsely depressed results. cea, folic acid, om-ma (ca125) and vitamin b12 exhibited falsely elevated results with the determined biotin concentrations.3gallergy specific ige, anti hbc, br-ma (ca15-3), ck-mb, epo, gastrin and thyroglobulin exhibited falsely depressed results with determined biotin concentrations.
  • Action
    Siemens is providing users with updated information regarding biotin interference and updating the Instructions for Use (IFU).

Device

IMMULITE/IMMULITE 1000 IMMULITE 2000/IMMULITE 2000 XPi Assays. An in vitro diagnostic medical dev...
  • Model / Serial
    IMMULITE/IMMULITE 1000 IMMULITE 2000/IMMULITE 2000 XPi Assays. An in vitro diagnostic medical device (IVD)Affected Multiple Assay Numbers, Catalogue Numbers and Material NumbersARTG: 179719, 180780, 180969, 179720, 179721
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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