Events

Recall of Dimension Vista Systems - Theophylline (THEO) 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 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-2014-RN-01206-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-11-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01206-1
  • 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 abnormal reaction flags (e145: abnormal reaction) with dimension vista theophylline (theo) flex reagent cartridge lot 14148ac. the abnormal reaction flags can occur on calibration, qc and/or patient samples. any result with an abnormal reaction flag is deemed non-reportable as described in the dimension vista operator’s guide.The potential for an abnormal reaction flagged result when using the affected lots would prevent reporting theophylline values. the frequency of obtaining abnormal reaction flags as a result of this issue is variable among customer sites ranging from 0 flags to 100% of results flagged.
  • Action
    Siemens is requesting their customers to discontinue use and discard any remaining inventory of Dimension Vista THEO lot 14148AC. Siemens will replace any unused inventory of the affected lot at no charge. This action has been closed-out on 02/03/2016.

Device

Dimension Vista Systems - Theophylline (THEO) Flex Reagent Cartridge. An in vitro diagnostic medi...
  • Model / Serial
    Dimension Vista Systems - Theophylline (THEO) Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD).Catalogue Number: K4071Lot Number: 14148ACARTG Number: 182220
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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