Events

Recall of Dimension Vista ALP Calibrator (clinical chemistry enzyme). An in vtiro diagnostic medical device (IVD)

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-2012-RN-01048-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-11-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01048-1
  • 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 has received customer inquiries regarding correlation slope bias when comparing the dimension vista alp method to the dimension® alp method. siemens' internal investigation has confirmed that the activity of the dimension vistaalp cal, kc330, changes as the product ages and contributes to this correlation slope bias as well as accuracy shift. the magnitude of the accuracy shift is the same for qc and patient samples and does not exceed the allowable bias for the dimension vista alp assay. in order to ensure better correlation and accuracy, the shelf life for the dimension vista alp cal has been decreased from 12 months to 4 months.
  • Action
    Siemens is providing work around instructions for users to implement.

Device

Dimension Vista ALP Calibrator (clinical chemistry enzyme). An in vtiro diagnostic medical device...
  • Model / Serial
    Dimension Vista ALP Calibrator (clinical chemistry enzyme). An in vtiro diagnostic medical device (IVD)Catalogue Number: KC330Siemens Material Number: SMN 10445181Lot number recalled : 2AD052Lot numbers whose shelf life will be reduced: 2GD011 and higherARTG Number: 181688
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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