Events

Recall of CELLPACK DST

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
    21829
  • Event Risk Class
    III
  • Event Initiated Date
    2014-10-16
  • 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
    Innacurate product labelling on reagent. the expiration date on the label states that it is to be used within 30 days of opening but the in reality it is acceptable for use within 60 days of opening. no calim of performance issue or harm to patients has occured.

Device

CELLPACK DST
  • Model / Serial
    Model Catalog: DST-300A (Lot serial: Y4001 Y4002 Y4003); Model Catalog: DST-300A (Lot serial: Y3001 Y3002 Y3003)
  • Product Description
    CellPack DST
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

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