Recall of IMMULITE 2000 / IMMULITE 2000 XPi ACTH Control module (Used for the detection of Adrenocorticotropic 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-01028-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-10-10
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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
    It has been confirmed that there is a tendency for an increase in the mean values obtained with the laccm control lot 0018 when used with immulite 2000/immulite 2000 xpi kit lots 240 and above.
  • Action
    Siemens is providing work around instructions for users to follow.

Device

  • Model / Serial
    IMMULITE 2000 / IMMULITE 2000 XPi ACTH Control module (Used for the detection of Adrenocorticotropic hormone). An in vitro diagnostic medical device (IVD)Catalogue Number: LACCMLot Number: 0018Siemens Material Number: 10385382
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    DHTGA