Recall of Device Recall Unicel DxH 800 Coulter Cellular Analysis System

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
  • Event ID
  • Event Risk Class
    Class 3
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Counter, differential cell - Product Code GKZ
  • Reason
    Issue 1: the system will substitute or omit the characters # @ 1 \ ] ' ( i ) - when the instrument is configured in a language other than english, chinese or japanese. example: using the character @, a substitution in the string '123@456' would result in '123#456' and an omission would result in '123456'. issue2: the characters 7 " and * (question mark, quotation mark, and asterisk) used as part.
  • Action
    Beckman Coulter, Inc. issued "Urgent: Product Corrective Action" notifications dated February 12, 2010. Consignees were informed of the affected product and instructed on proper actions. The firm also asked that the enclosed response forms be returned. For further information, contact your local Beckman Coulter Representative or call 1-800-526-7694.


  • Model / Serial
    Part number: 629029; All Serial Numbers.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Distributed Nationwide and Canada.
  • Product Description
    Unicel¿ DxH 800 Coulter¿ Cellular Analysis System. Beckman Coulter, Inc. Brea, CA. || Quantitative, automated hematology analyzer and for in vitro diagnostic use in screening patient populations found in clinical laboratories.
  • Manufacturer


  • Manufacturer Address
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Manufacturer Parent Company (2017)
  • Source