Events

Recall of Berichrom Heparin (used in the quantitative and/or qualitative determination of tests associated with the coagulation cascade) (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-2013-RN-00904-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-08-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00904-1
  • 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
    During recent investigations, siemens healthcare diagnostics has observed that the affected lots have shown reduced on board stability while used on bcs/bcs xp system or sysmex ca-7000 system as demonstrated by testing appropriate controls e.G. berichrom heparin control 1. the complaints received indicate that there is the potential for invalid runs. although unlikely, it is possible that an erroneously low heparin value may be reported which may trigger a higher dose of heparin therapy which could increase the risk of bleeding.
  • Action
    Siemens Healthcare is advising users to discard any remaining inventory of these lots. Affected lots will be replaced by Siemens Healthcare with unaffected stock. Siemens is not recommending lookback of previously reported Berichrom Heparin results since coagulation status changes over time.

Device

Berichrom Heparin (used in the quantitative and/or qualitative determination of tests associated ...
  • Model / Serial
    Berichrom Heparin (used in the quantitative and/or qualitative determination of tests associated with the coagulation cascade) (An in vitro diagnostic medical device (IVD))Catalogue Number: OWLD 11Siemens Material Number: 10446620Lot Numbers: 42007, 42082, 42483 and 42569ARTG Number: 178506
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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