Events

Recall of CYTOMICS FC 500 FLOW CYTOMETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    42874
  • Event Risk Class
    II
  • Event Initiated Date
    2004-02-18
  • 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
    Software anomaly due to sample id and run date remaining fixed on the flow page although the sample id and run date may have been changed by the operator. dk.

Device

CYTOMICS FC 500 FLOW CYTOMETER
  • Model / Serial
    Model Catalog: (Lot serial: RXP SoftwareV1 175260-175265); Model Catalog: (Lot serial: Cytomics RXP SoftwareV1 175488); Model Catalog: (Lot serial: 117884 Cytomics MXP SoftwareV1); Model Catalog: (Lot serial: 623560 CXP Software v1.0)
  • Product Description
    Cytomics CXP MXP RXP Software V1.0
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.