Recall of ACL Top Family of instruments (haemostasis testing systems). 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 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-2014-RN-00633-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-06-25
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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
    There is potential for a sample misidentification on the acl top family that only occurs following a specific set of steps combined with the inability of the system to read a specific sample rack barcode.
  • Action
    Werfen Australia is providing work around instructions to follow to mitigate the issue. A software update to correct the issue is in development and will be implemented once completed. This action has been closed-out on 11/02/2016.

Device

  • Model / Serial
    ACL Top Family of instruments (haemostasis testing systems). An in vitro diagnostic medical device (IVD). ACL TOP Part Number: 00000280000 ACL TOP CTS Part Number: 00000280020 ACL TOP 700 Part Number: 00000280010 ACL TOP 700 CTS Part Number: 00000280050 ACL TOP 700 LAS Part Number: 00000280030 ACL TOP 500 CTS Part Number: 00000280040 ACL TOP 300 CTS Part Number: 00000280060
  • Product Classification
  • Manufacturer

Manufacturer