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
    132851
  • Event Risk Class
    II
  • Event Initiated Date
    2016-06-24
  • 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
    Quality control (qc) results without a qc specimen id (sid) are being filed with patient results that follow it in the same message on instrument manager siemens dpc cirrus lmmulite/lmmulite/versacell (dpcimmui) driver. if the cirrus lmmulite lmmulite one lmmulite 1000 lmmulite 2000 lmmulite 2500 or lmmulite xpi instrument is running in uni-directional mode and is configured to automatically send qc results to the laboratory information system (lis) and specimen ids are not added to qc samples then qc results received by im without a specimen id will be added to the first specimen received after these qc results in the same astm message.

Device

INSTRUMENT MANAGER
  • Model / Serial
    Model Catalog: VX.XX.XX (Lot serial: driver version 8.00.0021); Model Catalog: VX.XX.XX (Lot serial: driver version 8.00.0020); Model Catalog: VX.XX.XX (Lot serial: driver version 8.00.0019); Model Catalog: VX.XX.XX (Lot serial: driver version 8.00.0018); Model Catalog: VX.XX.XX (Lot serial: driver version 8.00.0017)
  • Product Description
    Instrument Manager
  • Manufacturer
    DATA INNOVATIONS LLC

Manufacturer

DATA INNOVATIONS LLC