Events

Recall of Osteocalcin assay run on IMMULITE 2000 & IMMULITE 2000 XPi 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-00036-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-01-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00036-1
  • 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 under recovery up to 50% in patient values across the assays reportable range with the affected immulite 2000/immulite 2000 xpi osteocalcin (l2kon2) kit lots. quality control materials will not detect the bias.Osteocalcin can serve as a measure of increased bone resorption in some patient. depending upon the treatment approach, the measurement of osteocalcin may correlate to therapy. in some patients risk of osteoporosis correlates of increasing values of osteoclacin.
  • Action
    Siemens Healthcare is advising users to discontinue and discard affected lots. Siemens does not currently have a replacement for this product. Siemens is recommending discussing this notice with the medical director regarding the need to review previous test results, conduct patient follow and / or repeat testing for patients tested with the affected lots.

Device

Osteocalcin assay run on IMMULITE 2000 & IMMULITE 2000 XPi analysers. An in vitro diagnostic medi...
  • Model / Serial
    Osteocalcin assay run on IMMULITE 2000 & IMMULITE 2000 XPi analysers. An in vitro diagnostic medical device (IVD)Test Code: OCNCatalogue Number: L2KON2Lot Numbers: 218, 219, 220 & 221Siemens Material Number: 10381477ARTG Number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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