Events

Recall of IMMULITE 2000/IMMULITE 2000 XPi water and liquid waste bottles

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-2015-RN-00201-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00201-1
  • 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 is conducting a correction for the immulite 2000 / immulite 2000 xpi immunoassay systems water and liquid waste bottles received from may 2013. siemens has identified that the water and liquid waste bottle assemblies were manufactured with a quality issue. the opening of both bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.This could result in the aspiration straw dislodging from the bottle causing the instrument to aspirate air into the fluidic line potentially resulting in discordant results.
  • Action
    Siemens is providing work around instructions to assist end users to mitigate risk and identify faulty bottle openings. If a faulty bottle is identified end users are requested to contact Siemens for a replacement.

Device

IMMULITE 2000/IMMULITE 2000 XPi water and liquid waste bottles
  • Model / Serial
    IMMULITE 2000/IMMULITE 2000 XPi water and liquid waste bottlesSiemens Material Numbers: 10291586 and 10291587ARTG number: 174399
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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