Events

Recall of Bulk Loader Module for cobas p 471 centrifuge unit(Automated clinical analytical systems designed to analyse biological samples for in vitro diagnostic purposes)

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-00923-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-09-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00923-1
  • 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
    Roche has received a complaint that one sample tube was opened inadvertently in a bulk loader module (blm) during the internal system transport. the opened sample tube fell down into the funnel and the sample material was spilled, contaminating the system and other samples on their outer surface. sample material could not be used to carry out the analysis.
  • Action
    To prevent the above malfunction, a hardware modification kit has been developed and will be released by the end of September 2015, with subsequent installation by a Roche field service engineer. Until the modification kit is installed Roche is requesting that if the issue occurs end users must carryout a complete instrument clean according to the Bulk Loader Module (BLM) operator manual. This action has been closed-out on 29/08/2016.

Device

Bulk Loader Module for cobas p 471 centrifuge unit(Automated clinical analytical systems designed...
  • Model / Serial
    Bulk Loader Module for cobas p 471 centrifuge unit(Automated clinical analytical systems designed to analyse biological samples for in vitro diagnostic purposes)Part Number: 07084285001All Lot NumbersAll Software versionsARTG Number: 212706
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited