Events

Recall of Dimension Enzyme II Calibrator (used with Dimension clinical chemistry system). 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-00661-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00661-1
  • 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 of positive shift of patient and qc results when the alti assay is calibrated with the affected dimension enzyme ii calibrator lots. internal investigation has confirmed that patients, quality control, and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibrator lots. there is no risk to patients however there may be a delay in results.
  • Action
    Siemens has reassigned the bottle values of all Enzyme II calibrator lots currently in date. Laboratories may expect to observe a downward shift of approximately 8% in QC, patient samples and proficiency testing materials when reassigned bottle values are used for calibration. Siemens recommends recalibration of existing Alanine Aminotransferase (ALTI) flexes and future calibrations using the reassigned calibrator bottle values for lots provided. A review of previously generated results due to this issue is at the discretion of the laboratory.

Device

Dimension Enzyme II Calibrator (used with Dimension clinical chemistry system). An in vitro diagn...
  • Model / Serial
    Dimension Enzyme II Calibrator (used with Dimension clinical chemistry system). An in vitro diagnostic medical device (IVD)Product Code: ENZ II CALCatalogue Number: DC143Siemens Material Number (SMN): 10476170Multiple Lot Numbers and Expiry Dates affectedARTG Number: 181688
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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