Events

Recall of ADVIA Centaur Systems Calibrator E (Used with Advia Centaur, Centaur XP, Centaur XPT Systems). 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 Healthcare Pty Ltd.

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-2016-RN-00180-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00180-1
  • 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 has confirmed a lot to lot bias with calibrator e for the advia centaur testosterone assay. siemens’ internal investigation demonstrates:· an average positive bias of 17% across the assay range with calibrator e kit lots ending in 42. · an average negative bias of 7% across the assay range with calibrator e kit lots ending in 43. · the positive bias of lots ending in 42 to the master curve compared to the negative bias of lots ending in 43 to the master curve is the main driver for the negative bias between values generated with lots ending in 42 and 43. the bias of the calibrators to the master curve has been corrected with calibrator e kit lots ending in 44. the risk to health as a result of this issue is negligible. the biases observed across the assay range would not impact clinical management of patients being evaluated for androgen disorders or chemical castration.
  • Action
    Siemens is advising users that Calibrator E with lots ending in 42 and 43 can continued to be used to calibrate Testosterone on the Centaur CP system. Lots ending in 44 and above should be used for other Centaur systems. A review of previously generated results due to this issue is at the discretion of the laboratory.

Device

ADVIA Centaur Systems Calibrator E (Used with Advia Centaur, Centaur XP, Centaur XPT Systems). An...
  • Model / Serial
    ADVIA Centaur Systems Calibrator E (Used with Advia Centaur, Centaur XP, Centaur XPT Systems). An in vitro diagnostic medical device (IVD)Catalogue Numbers: 04634452, 04634762, 04636889Siemens Material Number (SMN): 10309079, 10321075, 10335532Multiple Lot numbers affectedARTG Number: 175698
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA