Events

Recall of Product-CD30 (Ber-H2) Incorrect Primary Antibody Expiration Dating

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

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-00690-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-07-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00690-1
  • 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
    Ventana medical systems, inc. (ventana) would like to inform you that the expiration date of the ventana cd30 (ber-h2) mouse monoclonal primary antibody (part number 790-4858, roche material number 07007841001) was inadvertently labelled with a 24 month expiration date for the referenced lot numbers. based on extensive testing of the affected lots, ventana can only support an 18 month expiration date.
  • Action
    Roche is requesting their customers to stop use of the affected product. Roche is also recommending that any clinical cases tested after the actual expiration date be re-tested in accordance with your local laboratory practices and policies, especially if tissue and/or same-slide controls were not performed in association with the original case. This action has been closed-out on 05/09/2016.

Device

Product-CD30 (Ber-H2) Incorrect Primary Antibody Expiration Dating
  • Model / Serial
    Product-CD30 (Ber-H2) Incorrect Primary Antibody Expiration DatingAffected lot numbers: D04835Z, D09123, E00209, E03668, E04391, E05896ARTG Number: 175635
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited