Events

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
    Recall
  • Event ID
    55194
  • Event Risk Class
    Class 2
  • Event Number
    Z-1656-2010
  • Event Initiated Date
    2010-03-02
  • Event Date Posted
    2010-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90277
  • 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 diagnostic procedure, simulate-cdnr cycle, is not functioning properly. impact: there is a potential for inadequate sample preparation of samples following the use of this diagnostic function impacting wbc, differential, reticulocyte and/or nrbc results. issue 2: use of the auto prune function causes the deletion of quality control files. impact: if the last run for a control lot.
  • Action
    Beckman Coulter, Inc. issued an "Urgent: Product Corrective Action" notification dated March 10, 2010. Consignees were informed of the affected product and instructed on proper steps to take and requested to return the enclosed acknowledgement form. For further information, contact your local Beckman Coulter Representative or call 1-800-526-7694.

Device

Device Recall UniCel DxH 800 Coulter Cellular Analysis System
  • Model / Serial
    All Serial Numbers
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed Nationwide and Canada.
  • Product Description
    UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc. Brea, CA. || Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

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