Events

Recall of ADVIA Chemistry Systems Liquid Specific Protein Calibrator (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-2013-RN-00318-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-04-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00318-1
  • 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
    The system specific values (ssvs) for the rheumatoid factor (rf) assay have been reassigned for this lot. siemens has determined that the rheumatoid factor ssvs currently assigned to this lot may cause an average -15% shift in quality control and sample recovery.
  • Action
    Siemens is providing updated system specific values for the affected lot as a work around solution.

Device

ADVIA Chemistry Systems Liquid Specific Protein Calibrator (an in vitro diagnostic medical device...
  • Model / Serial
    ADVIA Chemistry Systems Liquid Specific Protein Calibrator (an in vitro diagnostic medical device (IVD))Siemens Material Number (SMN): 10311929Part Number: B03-4845-01Lot Number: 244560Expiration Date: 2014-05-28ARTG Number: 185171
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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