Events

Recall of StreamLAB Automation Solutions (Clinical Chemistry Sample Processors). 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-2012-RN-01047-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01047-1
  • 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 received reports from customers that the small pins at the bottom of the centre door panel of the input/output module, which protrude approximately 5/8 inch, have contributed to a trip and fall incident. customers are being asked to use caution when working in the area of the input/output module and to post the communication near or on the streamlab analytical workcell system.
  • Action
    Siemens is providing work around instructions for users to implement.

Device

StreamLAB Automation Solutions (Clinical Chemistry Sample Processors). An in-vitro diagnostic med...
  • Model / Serial
    StreamLAB Automation Solutions (Clinical Chemistry Sample Processors). An in-vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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