Events

Recall of RIA Coat-A-Count Androstenedione

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-00624-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00624-1
  • 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 received complaints regarding the coat-a-count direct androstenedione assay demonstrating a higher frequency of results >10 ng/ml (>25 nmol/l) compared to alternate platforms. through internal investigation siemens has determined that there is a potential of cross-reactivity in circulating physiological serum levels up to 8.82% detected with spironolactone and its two metabolites, canrenone and 7a-thiomethyl spironolactone with the ria cac direct androstenedione assay. the degree of cross-reactivity is dependent on the circulating dose in the patients’ serum.
  • Action
    Siemens is advising pathology laboratories that the assay should not be used on patients being treated with spironolactone due to cross reactivity. These patients should be tested using an alternative method. A look back using another test method may be required if a patient has been administered spironolactone.

Device

RIA Coat-A-Count Androstenedione
  • Model / Serial
    RIA Coat-A-Count AndrostenedioneCatalogue Number: TKAN1Siemens Material Number: 10381049Lot Numbers: 587 and aboveARTG Number: 210100
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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