Events

Recall of CELLEX PHOTOPHERESIS SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHO-CLINICAL DIAGNOSTICS.

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
    50380
  • Event Risk Class
    II
  • Event Initiated Date
    2011-09-07
  • 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
    Of 18000 treatments performed to date therakos received three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the cellex photopheresis system. the investigation suggests that heat generated in the centrifuge chamber may be responsible for red cell changes that may rarely result in post reinfusion hemolysis or hemoglobinuria. the purpose of the recall notification is to provide customers with recommended actions intended to reduce heat build-up in the centrifuge chamber of the cellex system.

Device

CELLEX PHOTOPHERESIS SYSTEM
  • Model / Serial
    Model Catalog: THERAKOS CELLEX (Lot serial: 40138); Model Catalog: THERAKOS CELLEX (Lot serial: 40223); Model Catalog: THERAKOS CELLEX (Lot serial: 40233); Model Catalog: THERAKOS CELLEX (Lot serial: 40234)
  • Product Description
    THERAKOS CELLEX Photopheresis System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS