Events

Recall of Sysmex CS-2000i and CS-2100i systems (Automated blood coagulation analysers). 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 Healthcare Pty Ltd.

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-2016-RN-01073-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01073-1
  • 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
    There is the potential for mismatched sample id's under a rare circumstance where the host computer connected to the instrument sends a measurement order irregularly to the instrument. the host computer displays a 'time out' error and when measuring the next sample displays the error 'host computer order is wrong' and overwrites the previous sample id with the current sample being measured. there is the potential for a mis-diagnosis as a result of the error, however there have been no reported injuries as a result of the issue.
  • Action
    Siemens is advising users to repeat the measurement of all samples in an affected sample rack when the instrument displays the error 'HC Order is wrong". A look-back at patient results is at the discretion of the laboratory director. If the error occurs, users should contact the Host Computer Vendor to confirm the interface protocol is running correctly.

Device

Sysmex CS-2000i and CS-2100i systems (Automated blood coagulation analysers). An in vitro diagnos...
  • Model / Serial
    Sysmex CS-2000i and CS-2100i systems (Automated blood coagulation analysers). An in vitro diagnostic medical device (IVD)Siemens Material Number : 10488064, 10488062All software versionsARTG Number:179939
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA