Events

Recall of Sysmex CS-2100i/2000i Systems (Coagulation Analysers), Software Versions: up to and incl. SW 00-60 (CS-2x00i). 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-00700-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00700-3
  • 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 of the device, sysmex corporation, has informed siemens healthcare diagnostics that in a rare occurrence, data attached with a flag indicating “low reliability” was auto-validated and transferred to the host, when settings of the instrument were such that “low reliability” or flagged data should not be validated. in these cases, the data displayed by the host computer does not include the “low reliability” flag.
  • Action
    Siemens is providing work around instructions for users to implement.

Device

Sysmex CS-2100i/2000i Systems (Coagulation Analysers), Software Versions: up to and incl. SW 00-6...
  • Model / Serial
    Sysmex CS-2100i/2000i Systems (Coagulation Analysers), Software Versions: up to and incl. SW 00-60 (CS-2x00i). An in vitro diagnostic medical device (IVD)Model Numbers: 06317410 (CS-2000i), 06372511 (CS-2100i)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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