Events

Recall of SYSTEM DI-60 MAIN UNIT

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

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
    51870
  • Event Risk Class
    III
  • Event Initiated Date
    2018-01-23
  • 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
    Sysmex america inc. has been made aware of a software defect on versions 6.0.1 and 6.0.2 running on the cellavision dm-series and sysmex di-60 that may cause comments to not be transmitted to the laboratory information system (lis). if all the following three conditions are met the comments will not be transmitted from the cellavision software to the lis: 1. the analyzer system computer server and remote review software installed is on version 6.0.1 or 6.0.2 and 2. the workflow with multiple slides for blood samples is used and 3. wbc rbc and plt comments are added to the last slide after it has been already signed.

Device

SYSTEM DI-60 MAIN UNIT
  • Model / Serial
    Model Catalog: CC286297 (Lot serial: 60044 - 60965); Model Catalog: BC188562 (Lot serial: NA)
  • Product Description
    SYSTEM DI-60 MAIN UNIT;SYSTEM DI-60 REMOTE REVIEW SOFTWARE
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

SYSMEX CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Sysmex Corp.
  • Source
    HC