Events

Recall of Berichrom Antithrombin III Kits. 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-00179-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-02-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00179-1
  • 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 that some packages of the berichrom antithrombin iii kit may contain a different substrate reagent lot as given in the package labelling. dependent on the instrument used, some instruments with automatic reagent identification may request a new calibration.The correct substrate reagent lot number is 520294. this issue has no impact on patient results.
  • Action
    Siemens Healthcare is advising users that the affected product will be replaced with unaffected stock. This action has been closed-out on 03/02/2017.

Device

Berichrom Antithrombin III Kits. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Berichrom Antithrombin III Kits. An in vitro diagnostic medical device (IVD)Catalogue Number: OWWR15, OWWR17Siemens Material Number (SMN): 10446672, 10446673Lot Number: 45029, 45027ARTG Number: 178559
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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