Recall of Enzygnost Anti-VZV/IgG(For in vitro diagnostic use in testing to provide information about infection with or exposure to the Varicella zoster virus (VZV)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare 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-00998-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-14
  • 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
    Enzygnost anti-vzv/igg lots can show a higher variation in homogeneity.
  • Action
    Siemens is requesting their customers to discontinue use and discard all affected lots of Enzygnost Anti-VZV/IgG. This action has been closed-out on 18/04/2017.

Device

  • Model / Serial
    Enzygnost Anti-VZV/IgG(For in vitro diagnostic use in testing to provide information about infection with or exposure to the Varicella zoster virus (VZV)Catalogue Number: OWLT15Material Number: 10446625Lot Number: 44218, 44309, 44565, 45077ARTG Number: 203348
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    DHTGA