Events

Recall of Dimension Tacrolimus (TACR) 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-2013-RN-00050-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-01-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00050-1
  • 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
    The manufacturer has confirmed customer complaints of low patient sample recovery with tacr flex, lot fa3316. quality control materials have not exhibited low recovery of the same magnitude.
  • Action
    Siemens is requesting customers to immediately discard any remaining Dimension TACR (DF107) Flex lot FA3316. Laboratory Directors are also being advised to review patient tests to determine if follow-up testing is required.

Device

Dimension Tacrolimus (TACR) Flex Reagent Cartridge, An in vitro diagnostic medical device (IVD)

Manufacturer

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