Events

Recall of Androstenedione assay run on Immulite, Immulite 1000, Immulite 2000, Immulite 2000XPi analysers. 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 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-00002-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-01-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00002-1
  • 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 over-recovery of samples with concentrations greater than 5.5ng/ml (19.2nmol/l) with the immulite/immulite 1000 and immulite 2000/ immulite 2000 xpi androstenedione assays. siemens has determined that these lots are linear up to a concentration of 5.5ng/ml (19.2nmol/l), instead of 10ng/ml (34.9nmol/l) as stated in the instructions for use (ifu). quality control materials at concentrations between 5.5ng/ml (19.2nmol/l) and 10ng/ml (34.9nmol/l) will detect this issue.
  • Action
    Siemens is advising their customers to use Quality Control materials with at least two levels having concentrations greater that 5.5ng/mL (19.2 nmols/L). Patient values of greater than 5.5ng/mL (19.2 nmols/L) should be verified using an alternate method.

Device

Androstenedione assay run on Immulite, Immulite 1000, Immulite 2000, Immulite 2000XPi analysers. ...
  • Model / Serial
    Androstenedione assay run on Immulite, Immulite 1000, Immulite 2000, Immulite 2000XPi analysers. An in vitro diagnostic medical device (IVD)Immulite/Immulite 1000Catalogue Number: LKA01Siemens Material Number: 10381158Lot Number: 409 and aboveImmulite 2000/Immulite 2000XPiCatalogue Number: L2KA02Siemens Material Number: 10381188Lot Number: 314 and aboveARTG Number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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