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
    55495
  • Event Risk Class
    Class 2
  • Event Number
    Z-1905-2010
  • Event Initiated Date
    2009-07-28
  • Event Date Posted
    2010-06-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90993
  • 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 confirmed an issue with the unicel dxh 800 during in-house testing. it was determined that there is a potential for a false increase in platelet results, due to micro-bubbles. this situation could present a risk of falsely increased platelet results in patient samples as diluent containers are depleted.
  • Action
    Beginning on July 29, 2009 Customers were contacted by Customer Technical Support (CTS) personnel and provided with the Product Corrective Action (PCA) letter. The PCA letter informed customers of the issue, the impact of the issue and actions/resolutions required by Beckman Coulter Service representative ad the affected consignee. The consignees were informed that their Beckman Coulter Service representative has made temporary changes to the Supplies setup. In addition to the Supplies setup change, consignees were instructed that one of the following workflow options must be implemented to ensure no results are affected. Please continue to follow one of the options listed below until a permanent fix is available. These options were given as: Option A: Monitor Diluent cycles or Option B: Unable to monitor Diluent cycles. The consignees were instructed that a long term solution to eliminate this risk is being developed and will be provided as soon as available. The consignees were instructed to please share this information with your laboratory staff. If they have any questions regarding this Product Corrective Action, please call 800-526-7694 in the United States or contact your local Beckman Coulter Representative.

Device

Device Recall Unicel DxH 800 Coulter Cellular Analysis System
  • Model / Serial
    Serial Numbers: AN07020, AN05001, AN05004, AM44041, AN07015, AM51052, AN10031
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide to: AZ, LA, IL, NY, PA & TN
  • Product Description
    Unicel DxH 800 Coulter Cellular Analysis System, || Part number(s): 629029
  • 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