Events

Recall of EPICS XL/MCL ANALYZER

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
    28131
  • Event Risk Class
    I
  • Event Initiated Date
    2018-01-11
  • 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
    As a result of customer complaints and subsequent internal investigations beckman coulter has determined that an internal electronic component on the circuit "amplifier" boards in the epics xl/xl-mcl flow cytometry systems may be affected by a manufacturing defect. each epics xl/xl-mcl system contains up to seven (7) of the potentially affected amplifier boards. all instruments are potentially impacted.

Device

EPICS XL/MCL ANALYZER
  • Model / Serial
    Model Catalog: 626552 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 6604988 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 626554 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 626551 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 6605464 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 6605628 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 626553 (Lot serial: ALL SOFTWARE VERSIONS)
  • Product Description
    EPICS XL/MCL ANALYZER;CYTOMICS FC 500 MPL (FLOW CYTOMETER) - INSTRUMENT;COULTER EPICS SERIES FLOW CYTOMETER SYSTEM - EPICS XL ANALYZER;CYTOMICS FC 500 FLOW CYTOMETER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.