Events

Recall of ACT 5DIFF SERIES HEMATOLOGY ANALYZER

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
    31758
  • Event Risk Class
    III
  • Event Initiated Date
    2004-12-23
  • 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
    The lyse reagent was distributed inside a white unlabeled carton. the reagent bottle is labeled however to prevent exposure to light it should be kept within the white box which has not label.

Device

ACT 5DIFF SERIES HEMATOLOGY ANALYZER
  • Model / Serial
    Model Catalog: (Lot serial: 03802B)
  • Product Description
    ACT 5Diff WBC Lyse reagent
  • Manufacturer
    BECKMAN COULTER INC.

Manufacturer

BECKMAN COULTER INC.