Events

Recall of Sysmex Automated Blood Coagulation Analyzer CS-2100i and 2000i. 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-01252-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01252-1
  • 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 become aware about a software bug with sysmex cs-2100i/2000i analyzers. when the operator registers an order for micro mode and tries to modify the order, there is a risk of a mismatch between the results and sample id numbers. under certain circumstances, measurement results could be assigned to a wrong sample.
  • Action
    Siemens is providing users with work around instructions to follow. A software update will be implemented to permanently correct the issue.

Device

Sysmex Automated Blood Coagulation Analyzer CS-2100i and 2000i. An in vitro diagnostic medical de...
  • Model / Serial
    Sysmex Automated Blood Coagulation Analyzer CS-2100i and 2000i. An in vitro diagnostic medical device (IVD)Catalogue Numbers: SMN 10488583 and 10488585Siemens Reference Number: PH 14-002ARTG Number: 179939
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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