Events

Recall of Dimension TACR (Tacrolimus) Flex Reagent Cartridge (DF107), 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-00392-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-05-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00392-1
  • 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 previously communicated an issue with low bias on patient results for dimension tacrolimus flex reagent cartridge lot fa3316 (urgent medical device recall dc 13-02a and tga ref rc-2013-rn-00050-1). siemens will be implementing linking of specific dimension tacr calibrator lots with specific dimension tacr flex lots to ensure accurate recovery and continued traceability of patient results to the lcms reference method. due to the requirement for linked calibrators, lots 2ed072 and 2kd084 can no longer be used.
  • Action
    Siemens is requesting customers to immediately discard any remaining Dimension TACR (DF107) Flex lot 2ED072 and 2KD084. To ensure the correct linkage between calibrator and reagent lots, customers are requested to contact their Siemens customer service to order lot linked combinations.

Device

Dimension TACR (Tacrolimus) Flex Reagent Cartridge (DF107), An in vitro diagnostic medical device...

Manufacturer

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