Events

Recall of Device Recall UniCel DxH 600 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
    78611
  • Event Risk Class
    Class 2
  • Event Number
    Z-0237-2018
  • Event Initiated Date
    2017-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159890
  • 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
    The shield for the single-tube station on the dxh instrument may interfere with sample aspiration in the open vial position.
  • Action
    The firm notified its consignees of the recall on 11/03/2017 by letter. The letter stated the issue and provided the following instructions: ¿ "To avoid a biohazardous spill, do not use the right (green) position of the Single-Tube Station for sample aspiration until the shield is removed. ¿ You may remove the shield following the instructions in Attachment 1 or contact your local Beckman Coulter Representative for further assistance."

Device

Device Recall UniCel DxH 600 Coulter Cellular Analysis System
  • Model / Serial
    Serial Number AZ06682
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, AR, HI, CA, OH, WA, MD, Canada, Japan
  • Product Description
    UniCel DxH600, Part Number B23858, automated hematology analyzer || (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA