Events

Recall of LEUKOSURE ENUMERATION KIT

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
    69169
  • Event Risk Class
    II
  • Event Initiated Date
    2010-06-07
  • 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
    There is incorrect activity levels stated on the instructions for use labeling in the leukosure enumeration kit due to the inaccurate activity values provided by the supplier for the raw material ribo-nuclease a type iii-a utilized as a component of the leukosure stain reagent. the activity value for these lots is 3.25ku/ml as compared to 4ku/ml as stated in the product labeling. alteration of the staining enumeration of white blood cells (wbc) in blood component preparation might produce falsely high values of white blood cells in samples with high levels of residual rna. these high values may result in the the blood component being considered inappropriate for use in transfusions thereby reducing the availability of blood for transfusion procedures. the high values may also result in unnecessary reprocessing of the blood component.

Device

LEUKOSURE ENUMERATION KIT
  • Model / Serial
    Model Catalog: 175621 (Lot serial: 5621013K); Model Catalog: 175621 (Lot serial: 5621012K); Model Catalog: 175621 (Lot serial: 5621014K)
  • Product Description
    LEUKOSURE ENUMERATION KIT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.