Events

Recall of IMMUNO-TROL CELLS

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
    25529
  • Event Risk Class
    III
  • Event Initiated Date
    2005-09-01
  • 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
    Immuno-trol & immuno-trol low cells unable to recover cd19 values using cyto-stat cd3 (igg1)-fitc/b4-rd1 6605015 cs b4-fitc pn 6603859 or cs b4-rd1 pn 6603846 when analyszed as per instructions.

Device

IMMUNO-TROL CELLS
  • Model / Serial
    Model Catalog: 6607098 (Lot serial: 760943F); Model Catalog: 6607077 (Lot serial: 758740F); Model Catalog: 6607098 (Lot serial: 758740F); Model Catalog: 6607077 (Lot serial: 758739F); Model Catalog: 6607077 (Lot serial: 758738F); Model Catalog: 6607098 (Lot serial: 758738F); Model Catalog: 6607077 (Lot serial: 760943F); Model Catalog: 6607098 (Lot serial: 758739F)
  • Product Description
    Immuno-trol & Immuno-trol Low cells
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.