Events

Recall of Calibrator E used for calibration of the ADVIA Centaur Systems Cortisol, Progesterone and Testosterone assays

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-01060-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-10-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01060-1
  • 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 identified a positive bias for calibrator e kit lots ending in 38 and 39 with the advia centaur systems cortisol and progesterone assays compared to the respective master curves. patient serum samples evaluated with the advia centaur cortisol assay and calibrated with affected lots of calibrator e kit demonstrate an average positive bias of 16% across the assay range with a maximum bias of 28%. patient serum samples evaluated with the advia centaur systems progesterone assay and calibrated with affected lots of calibrator e kit demonstrate a positive bias with samples above 30 ng/ml. the average positive bias on the advia centaur/advia centaur xp is 20% with a maximum bias of 39%. the average positive bias on the advia centaur cp is 17% with a maximum bias of 35%.The advia centaur systems testosterone assay is not affected by this correction.
  • Action
    Siemens is notifying their customers of the potential for positive bias when using the affected calibrators. As the bias only occurs outside of the useful clinical range the calibrators can continue to be used. Unaffected calibrators can be ordered if required. This action has been closed-out on 01/03/2016.

Device

Calibrator E used for calibration of the ADVIA Centaur Systems Cortisol, Progesterone and Testost...
  • Model / Serial
    Calibrator E used for calibration of the ADVIA Centaur Systems Cortisol, Progesterone and Testosterone assaysCatalogue Number: 04634452Siemens Material Number: 10309079Multiple kit lot numbers affectedARTG Number: 175698
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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