Events

Recall of INSTRUMENT MANAGER

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

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
    137869
  • Event Risk Class
    I
  • Event Initiated Date
    2013-01-15
  • 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
    When using the roche cobas e411 (rchce41i) driver version 8.00.0001 or 8.00.0002 if there is a barcode read error the current sample may be identified as the last sample id that was in that rack or disk position potentially causing sample mismatch. if the last sample had any pending tests in the orders database test selection would be downloaded to the instrument with the incorrect sample id and results would be reported on the wrong sample.

Device

INSTRUMENT MANAGER
  • Model / Serial
    Model Catalog: 8.00.0002 (Lot serial: Version 8.00.0002); Model Catalog: 8.00.0001 (Lot serial: Version 8.00.0002); Model Catalog: 8.00.0002 (Lot serial: Version 8.00.0001); Model Catalog: 8.00.0001 (Lot serial: Version 8.00.0001)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Product Description
    Instrument Manager Software (using Roche Cobas e411 driver)
  • Manufacturer
    DATA INNOVATIONS LLC

Manufacturer

DATA INNOVATIONS LLC