Events

Recall of Calibrator A used with ADVIA Centaur FT4 (free thyroxine) assay on the 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-2017-RN-00092-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00092-1
  • 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 a negative bias for the advia centaur ft4 assay when used with calibrator a kit lots ending in 90 on the advia centaur, advia centaur xp and advia centaur xpt systems. upon internal investigations siemens observed an average bias, when compared to calibrator a lots ending in 89, of -11% (range -28 to 7%) for ft4 dose of < 0.89ng/dl (<11.5pmol/l), -5% (range -14 to 0%) for 0.89ng/dl to 1.76ng/dl (11.5 to 22.7pmol/l) and -7% (range -16 to 3%) for >1.76ng/dl (>22.7pmol/l). when this issue occurs, the potential exists for misinterpretation of ft4 values as below the reference interval listed in the ifu when truly normal. in addition, siemens healthcare diagnostics confirmed the potential for calibration failures due to above limit calibrator rlu %cvs when using calibrator a kit lots ending in 90 with the ft4 assay. the performance of the ft4 assay when used with calibrator a kit lots ending in 90 on the advia centaur cp system is not affected.
  • Action
    Siemens is advising Advia Centuar FT4 assay customers using the Advia Centaur, Centaur XP, Centaur XPT Systems to discontinue use of and discard the affected Calibrator A kit lots ending in 90, and to use Calibrator A kit lots ending in 91 to calibrate the FT4 assay on these Systems. Siemens will replace affected stock. The information provided in the customer letter is to be reviewed by the Medical Director, with a review of previously generated results at the discretion of the laboratory. Advia Centaur FT4 assay customers using the Advia Centaur CP System can continue to use all available Calibrator A lots including those ending in 90.

Device

Calibrator A used with ADVIA Centaur FT4 (free thyroxine) assay on the ADVIA Centaur, Centaur XP,...
  • Model / Serial
    Calibrator A used with ADVIA Centaur FT4 (free thyroxine) assay on the ADVIA Centaur, Centaur XP, Centaur XPT Systems. An in vitro diagnostic medical device (IVD).Catalogue Number: 10285903Siemens Material Number: 10285903Lot Numbers: 07995A90, 08451A90, 16035A90, 32420A90, 43871A90, 59675A90, 62739A90Expiry Date: 24 July 2017ARTG Number: 175698
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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