Events

Recall of Dimension Vista Calcium (CA) Flex reagent cartridge. 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-2018-RN-00106-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00106-1
  • 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 affected dimension vista calcium (ca) flex reagent cartridge may produce erroneously low results from specific well sets. quality control (qc) may not detect the issue prior to patient testing if the ca calibration and qc are both processed in either an affected or unaffected well set.If ca reagent calibration is performed using an unaffected well set and qc and samples are subsequently processed using an affected well set, ca results may be falsely depressed, with observed biases from -0.075 mmol/l] to -0.7 mmol/l. if a ca reagent calibration is performed using an affected well set, and qc and patient samples are subsequently processed using an unaffected well set, ca results may be falsely elevated. the observed bias for serum, plasma, and urine specimens are similar.
  • Action
    Siemens Healthcare is advising users to discontinue use of, and discard the Dimension Vista Calcium Flex reagent lot 17171BD.

Device

Dimension Vista Calcium (CA) Flex reagent cartridge. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Dimension Vista Calcium (CA) Flex reagent cartridge. An in vitro diagnostic medical device (IVD)Catalogue Number: K1023Siemens Material Number: 10445160Lot Number: 17171BDARTG Number:181686
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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