Events

Recall of IMMULITE 1000, 2000, 2000 XPi - IGF-I Control Module (Used for the detection of insulin like Growth Factor hormone). 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-2012-RN-01022-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-10-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01022-1
  • 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 confirmed the following: · a negative bias against the mean values obtained with the lgcocm control lot 0026 level 2 when used with immulite®/immulite® 1000 (lkgf1, smn 10381403) kit lots 322 and above·an increase of mean values obtained with the lgcocm control lots 0025, 025l, and 0026 when used with immulite® 2000/immulite® 2000 xpi igf-i (l2kgf2, smn 10381448) kit lots 486 and 487.
  • Action
    Siemens is providing work around instructions for users to implement.

Device

IMMULITE 1000, 2000, 2000 XPi - IGF-I Control Module (Used for the detection of insulin like Grow...
  • Model / Serial
    IMMULITE 1000, 2000, 2000 XPi - IGF-I Control Module (Used for the detection of insulin like Growth Factor hormone). An in vitro diagnostic medical device (IVD)Catalogue number: LGCOCMMaterial number: 10385387Lot numbers: 025L, 0025 & 0026ARTG Number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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