Events

Recall of COBAS 8000 DATA MANAGER

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
    28734
  • Event Risk Class
    III
  • Event Initiated Date
    2015-05-26
  • 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
    Potential issue with the cobas 8000 data manager system (all versions) where the option "automatic patient masking when qc error" option does work correctly. this functionality does not work if the results for the last measured control level for this test is valid. as a consequence the results for the measured samples would not be released and forwarded to host due to the qc error.

Device

COBAS 8000 DATA MANAGER
  • Model / Serial
    Model Catalog: 06888160001 (Lot serial: N/A); Model Catalog: 07267657001 (Lot serial: N/A)
  • Product Description
    COBAS 8000 DATA MANAGER
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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