Events

Recall of COULTER CLONE & CYTO-STAT/COULTER CLONE T8 MONOCLONAL ANTIBODY

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
    50168
  • Event Risk Class
    III
  • Event Initiated Date
    2006-03-31
  • 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
    Appearance was recorded as "white plug" during product release but qc specification states "yellow-orange plug." inconsistencies between qc release specifications and products/package inserts were identified.

Device

COULTER CLONE & CYTO-STAT/COULTER CLONE T8 MONOCLONAL ANTIBODY
  • Model / Serial
    Model Catalog: 6602385 (Lot serial: 702803F); Model Catalog: 6602385 (Lot serial: 702805RF); Model Catalog: 6602385 (Lot serial: 702807F); Model Catalog: 6603511 (Lot serial: 716204F); Model Catalog: 6604625 (Lot serial: 745817F); Model Catalog: 6604625 (Lot serial: 745816F); Model Catalog: 6604625 (Lot serial: 745815F); Model Catalog: 6603511 (Lot serial: 716205F); Model Catalog: 6603511 (Lot serial: 716206F); Model Catalog: 6603511 (Lot serial: 716206F1); Model Catalog: 6603511 (Lot serial: 716208F); Model Catalog: 6602389 (Lot serial: 702704RF); Model Catalog: 6602389 (Lot serial: 702705F); Model Catalog: 6602434 (Lot serial: 703409F); Model Catalog: 6602434 (Lot serial: 703406RF)
  • Product Description
    Coulter Clone T8-FITC
  • Manufacturer
    BECKMAN COULTER INC.

Manufacturer

BECKMAN COULTER INC.