Events

Recall of Sysmex CS-2000i/CS-2100i/CS-5100 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 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-00843-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00843-1
  • 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 confirmed a carry-over risk on sysmex cs systems due to the applications using ca-clean i (964-0631-3) for sample probe rinse. under certain circumstances, the carry-over might impact results for factor v with innovin, factor xii with dade actin fsl, berichrom f xiii, innovance d-dimer assays. in case of innovance d-dimer, only frozen samples are concerned by a potential carry-over. no impact by carry-over was observed with innovance d-dimer when using fresh normal plasma or control plasma.
  • Action
    Siemens Healthcare Diagnostics is advising the user to run all affected above mentioned test applications (Protein C with Protein C Reagent, Protein S with Protein S Ac Reagent and Factor V Leiden with ProC Global Reagent) together in a “Batch Mode” and perform an extra prime and rinse step at the end of the batch. Siemens Healthcare Diagnostics is working on a solution to fix the issue and will communicate when a solution is available. Siemens does not recommend a look back of previously generated results since the coagulation status changes over the time, and does recommend that this communication is reviewed with the laboratory medical director.

Device

Sysmex CS-2000i/CS-2100i/CS-5100 Automated blood coagulation analysers. An in vitro diagnostic me...
  • Model / Serial
    Sysmex CS-2000i/CS-2100i/CS-5100 Automated blood coagulation analysers. An in vitro diagnostic medical device (IVD)Catalogue Numbers: 10488064, 10488062, 10709128Affected Applications: Protein C with Protein C Reagent (OQYG11), Protein S with Protein S Ac Reagent (OPAP03) and Factor V Leiden with ProC Global Reagent (OQLS13)ARTG number:179939
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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