Events

Recall of Berichrom Protein C on Sysmex CA-1500, CA-7000, CS-2000i and CS-5100 instruments. 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-2015-RN-00426-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00426-1
  • 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 affected berichrom protein c product lots may lead to a failure of calibration on the above sysmex instruments, where the calibration curve is indicated as invalid due to the 0% point of the calibration.
  • Action
    Siemens advises that in case the Berichrom Protein C calibration curve on your system is indicated as being invalid due to the 0% calibration point the mentioned calibration point has to be set manually to “0” dOD.

Device

Berichrom Protein C on Sysmex CA-1500, CA-7000, CS-2000i and CS-5100 instruments. An in vitro dia...
  • Model / Serial
    Berichrom Protein C on Sysmex CA-1500, CA-7000, CS-2000i and CS-5100 instruments. An in vitro diagnostic medical device (IVD).Berichrom Protein C Catalog numbers: 10446499 and 10446500Lot numbers: 45059 and subsequent, 44851 also affectedARTG number: 178559An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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