Events

Recall of COBAS 8100 BRF SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ROCHE DIAGNOSTICS.

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
    34814
  • Event Risk Class
    II
  • Event Initiated Date
    2017-02-28
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Following internal investigation of a customer complaint the manufacturer identified a situation where the cobas 8100 system reformatter module brf sw version 02-xx may cause sample racks crash potentially leading to be shaken and specimen to be spilled. there could be an impact on the test performance since a cross-contamination cannot be excluded and could lead to erroneous results. the manufacturer advised us of this on 20-feb-2017.

Device

COBAS 8100 BRF SYSTEM
  • Model / Serial
    Model Catalog: MODULE BRF SW (Lot serial: Version 02-XX)
  • Product Description
    COBAS 8100 BRF SYSTEM
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

ROCHE DIAGNOSTICS
  • Manufacturer Address
    LAVAL
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    HC