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
    55699
  • Event Risk Class
    Class 3
  • Event Number
    Z-2338-2010
  • Event Initiated Date
    2010-02-12
  • Event Date Posted
    2010-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91923
  • 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 recall was initiated after beckman coulter identified four (4) issues with the coulter lh 500 series system and the unicel dxh 800 coulter cellular analysis system: issue 1: there is a potential for misidentification to occur when the system is configured in languages other than english or chinese. the characters #,@,[,\,],`,{,|,}, or ~ are substituted or omitted in other languages. the issu.
  • Action
    The customer recall notification was initiated when Product Corrrective Actions letters with attached Customer Response form were sent on the week of February 15, 2010 to all customers who purchased the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System. The letters will provided the customers with an explanation of the problem identified and a work around. Customers with questions regarding the Product Corrective Action were instructed to call 800-526-7694 in the United States or Canada, or contact your local Beckman Coulter Representative.

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
    Throughout the United States and Canada
  • Product Description
    Unicel DxH 800 Coulter Cellular Analysis || System
  • 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