Events

Recall of ACL ELITE, ACL ELITE PRO, ACL 8000, ACL 9000 and ACL 10000 (coagulation analysers)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Werfen Australia 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-2012-RN-01163-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01163-1
  • 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
    Sporadically lowered aptt results outside of the clia allowable error limit of 15% when using these il locked test groups.Please note that this recall for product correction was originally initiated by beckman coulter in december 2011. the product and recall action was taken over by werfen australia in 2012.

Device

ACL ELITE, ACL ELITE PRO, ACL 8000, ACL 9000 and ACL 10000 (coagulation analysers)
  • Model / Serial
    ACL ELITE, ACL ELITE PRO, ACL 8000, ACL 9000 and ACL 10000 (coagulation analysers)
  • Manufacturer
    Werfen Australia Pty Ltd

Manufacturer

Werfen Australia Pty Ltd