Events

Recall of CELL-DYN 4000 SYSTEM - INSTRUMENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BGP PHARMA ULC.

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
    92393
  • Event Risk Class
    III
  • Event Initiated Date
    2000-12-05
  • 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
    Reports of low recovery of the platelet parameter in the open mode.

Device

CELL-DYN 4000 SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 01H61 (Lot serial: HC090)
  • Product Description
    CELL 26 CONTROL & HEMCAL
  • Manufacturer
    BGP PHARMA ULC

Manufacturer

BGP PHARMA ULC
  • Manufacturer Address
    ETOBICOKE
  • Source
    HC