Events

Recall of Sysmex CS-2100i and CS-5100 Automated blood coagulation analysers

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-2014-RN-00331-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-03-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00331-1
  • 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 of the analyser, sysmex corporation, has informed siemens healthcare diagnostics about an issue potentially affecting the factor viii results. the factor viii chromogenic assay generates a curve from which a percentage result is calculated. the sysmex cs-2100i and cs-5100 automated blood coagulation analysers may generate an irregular curve that under certain circumstances could lead to an erroneously increased result with a factor viii chromogenic assay. the irregular curve is not flagged by the system.
  • Action
    Siemens is advising their customers to run all Factor VIII Chromogenic assays in duplicate and confirm results in conjunction with the patient's clinical history. A software update is expected to be completed mid-2014 to correct the issue.

Device

Sysmex CS-2100i and CS-5100 Automated blood coagulation analysers
  • Model / Serial
    Sysmex CS-2100i and CS-5100 Automated blood coagulation analysersCatalogue Numbers: 10488062 and 10708128ARTG Number: 179939
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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