Events

Recall of TECHNICON HEMATOLOGY LEUCOCYTE REAGENTS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAYER 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
    50420
  • Event Risk Class
    II
  • Event Initiated Date
    1998-01-16
  • 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
    Presence of particulate matter in some bottles may cause high wbc background counts as evidence by increasing noise signals on peroxidase channel of this system causing flag to raise.

Device

TECHNICON HEMATOLOGY LEUCOCYTE REAGENTS
  • Model / Serial
    Model Catalog: (Lot serial: ITEM T01-1642-56); Model Catalog: (Lot serial: V07022X)
  • Product Description
    perox diluent 2 for technicon h system
  • Manufacturer
    BAYER INC.

Manufacturer

BAYER INC.
  • Manufacturer Address
    TORONTO
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    HC