Events

Recall of Leica ASP200S & Leica ASP300S. In vitro diagnostic medical devices (IVD)(Histology sample processing instruments)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Leica Microsystems 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-2015-RN-00717-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00717-1
  • 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
    Leica microsystems recently became aware that affected devices have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure. the missing alarm signal could lead to suboptimal quality tissue processing. in some cases, a re-biopsy of the patient could be necessary in order to obtain another viable tissue sample.
  • Action
    A Leica Service Engineer will correct the internal wiring and check the remote alarm functionality.

Device

Leica ASP200S & Leica ASP300S. In vitro diagnostic medical devices (IVD)(Histology sample process...
  • Model / Serial
    Leica ASP200S & Leica ASP300S. In vitro diagnostic medical devices (IVD)(Histology sample processing instruments)Leica ASP200S Product Code: 14048043625Serial Numbers: 5329, 5448, 5528, 5707Leica ASP300SProduct Code: 14047643514Serial Numbers: 5361, 5639, 5721, 5872, 6057
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd