Events

Recall of Dimension Tacrolimus (TACR) Flex Reagent Cartridge (An in vitro diagnostic medical device used with Dimension Clinical Chemistry Systems)

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-00340-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-04-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00340-1
  • 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 confirmed that the tacr method may demonstrate reduced on-board stability which may result in imprecise and inaccurate qc and patient results. investigations have shown that results may become imprecise when tacr flexes are stored on-board the instrument for 2 days or more. this imprecision typically presents as one or more elevated tacr results following a period of instrument inactivity. subsequent results from the same well may exhibit depressed values. the discordant high results may be elevated by as much as 2 times the expected value and the discordant low results may be depressed by as much as fifty percent. longer periods of on-board storage (> 2 days) coupled with periods of instrument standby may increase the magnitude of elevated and depressed results.
  • Action
    Siemens is asking customers to discard the remaining inventory of the affected stock. Also, Siemens is recommending discussing the issues with the laboratory director to determine if additional follow up is appropriate for TACR results reported in the laboratory. Beginning with TACR reagent cartridge lot BB4087, an “Alert Card” indicating that the on-board stability is limited to 8 hours, will be packaged with in the TACR cartons.

Device

Dimension Tacrolimus (TACR) Flex Reagent Cartridge (An in vitro diagnostic medical device used wi...
  • Model / Serial
    Dimension Tacrolimus (TACR) Flex Reagent Cartridge (An in vitro diagnostic medical device used with Dimension Clinical Chemistry Systems)Catalogue Number: DF107Lot Numbers: GB3099, GA3120, DB3141, GB3162, GB3176, FA3197, FA3267, FB3267ARTG Number: 182779
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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