Events

Recall of ACL Top Family of analysers used with HemosIL APTT reagent (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-2013-RN-00774-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00774-1
  • 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
    Werfen australia's investigation of recent customer complaints determined that an acl top family instrument can experience carry-over that causes shortened aptt clotting times on patient and/or quality control results. carry-over can occur when a hemosil synthaasil aptt reagent (pn 0020006800) is located in the same reagent rack as certain other hemosil reagents. the carry-over is introduced during the liquid height check that is performed upon rack insertion and is dependent on material position, the order of rack insertion, and the sequence in which the assays are performed.
  • Action
    Werfen is providing users with work around instructions to follow to mitigate the potential for this issue to occur. The requirement for a look back at previously reported results should be determined by the laboratory director. A software update is currently under development to correct this issue permanently. This action has been closed-out on 10/02/2016.

Device

ACL Top Family of analysers used with HemosIL APTT reagent (an in vitro diagnostic medical device...
  • Model / Serial
    ACL Top Family of analysers used with HemosIL APTT reagent (an in vitro diagnostic medical device (IVD))Models affected: ACL TOP, ACL TOP CTS, ACL TOP 700, ACl TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS and ACL TOP 300 CTSPart Numbers: 00000280000, 00000280010, 00000280020, 00000280030, 00000280040, 00000280050 and 00000280060ARTG Number: 197892, 98770
  • Manufacturer
    Werfen Australia Pty Ltd

Manufacturer

Werfen Australia Pty Ltd