Events

Recall of ADVIA Centaur Systems Calibrator U (Myoglobin). 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-01056-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01056-1
  • 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 that the advia centaur systems myoglobin assay is not meeting the analytical sensitivity claim of < 3 ng/ml (ug/l) as specified in the advia centaur myoglobin instructions for use (ifu), for all in-date reagent lots when evaluated with calibrator u kit lots ending in 63 and 64. values up to 12 ng/ml (ug/l) were observed.Siemens’ investigation has identified that certain calibrator u kit lots have drifted from the internal standardisation causing a positive shift in results. analytical sensitivity and alignment to the internal standardisation will be restored with the release of calibrator u kit lots ending in 65 (cu65) and higher. customers will observe a negative shift in quality control (qc) material and patient results when transitioning to cu65. as a result, revised qc targets and ranges for bio-rad controls have been established and published on the bio-rad website at qcnet.Com.
  • Action
    Siemens is advising that customers may continue to use Calibrator U lots CU63 and CU64 with any in-date reagent kit lot and current QC ranges. Revised QC targets and ranges are located on the Bio-Rad website at QCnet.com for use with CU65 and higher. Siemens is not recommending a review of previously generated results. However, a review of previously generated results is at the discretion of the laboratory. Update 7 October 2016: Siemens are advising that Calibrator kit lot CU65 is now avaliable. The use of lots CU63 and CU63 should be discontinued and the lots discarded.

Device

ADVIA Centaur Systems Calibrator U (Myoglobin). An in vitro diagnostic medical device (IVD)
  • Model / Serial
    ADVIA Centaur Systems Calibrator U (Myoglobin). An in vitro diagnostic medical device (IVD)Test code: Cal UCatalogue Number: 03684480Siemens Material Number: 10309996Kit Lots ending in 63 (Expiry 03 Oct 2016) and 64 (Expiry 17 Jan 2017)ARTG Number: 175075
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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