Events

Recall of Immulite 2000 / Immulite 2000 XPi Sex Hormone Binding Globulin (SHBG). 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-00196-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00196-1
  • 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 diagnostics has confirmed that the immulite 2000/immulite 2000 xpi sex hormone binding globulin (shbg) adjustor lots 124 and 125 packed with specific reagent lots do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8°c, as published in the instructions for use. reconstituted adjustors stored at 2-8°c after a two week (14 days) period may show a bias in patient samples and may result in quality control falling outside of established ranges. the reagent lots affected can exhibit an average bias of 14.5% at day 21 to 16.5% at day 28 (for shbg concentrations of 5 nmol/l to 170 nmol/l) during the open vial adjustor stability period of 30 days. the bias observed was not concentration dependent. this issue does not impact the immulite/immulite1000 platforms.
  • Action
    Siemens is advising that reconstituted adjustor lots 124 and 125 are to be stored at 2-8°C or -20°C for up to 14 days, after which they must be discarded. Based on the recommended calibration interval, this allows two calibration events at day 1 and 14 after opening the SHBG reagent kit. Replacement product can be requested from Siemens if adjustors available in the laboratory are not sufficient to utilise the full reagent kit. The customer letter should be reviewed by the laboratory Medical Director and review of previously generated results is at the discretion of the laboratory.

Device

Immulite 2000 / Immulite 2000 XPi Sex Hormone Binding Globulin (SHBG). An in vitro diagnostic med...
  • Model / Serial
    Immulite 2000 / Immulite 2000 XPi Sex Hormone Binding Globulin (SHBG). An in vitro diagnostic medical device (IVD).Catalogue Number: L2KSH2Siemens Material Number: 10381198Lot Numbers: 357 (Exp. 30 Jan 2017), 358 (Exp. 31 Mar 2017), 360 (Exp. 30 Apr 2017), 361 (Exp. 31 May 2017), 363 (Exp. 30 Jun 2017)ARTG number: 179720
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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