Events

Recall of GEN*S ANALYZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER 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
    32097
  • Event Risk Class
    II
  • Event Initiated Date
    2003-02-03
  • 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
    Erroneous elevated platelet count.

Device

GEN*S ANALYZER
  • Model / Serial
    Model Catalog: (Lot serial: GENS#s6605381 66053606605470); Model Catalog: (Lot serial: LH#s6605632 6605633 6605645)
  • Product Description
    GENS & LH 700 SERIES INSTRUMENTS
  • Manufacturer
    BECKMAN COULTER INC.

Manufacturer

BECKMAN COULTER INC.