Events

Recall of UniCel DxH 800 Analyzer

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
    58288
  • Event Risk Class
    Class 2
  • Event Number
    Z-1980-2011
  • Event Initiated Date
    2010-10-20
  • Event Date Posted
    2011-04-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98902
  • 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
    UniCel DxH 800 Analyzer - Product Code GKZ
  • Reason
    Sharp edges on drawer slides within the dxh800 floor stand (cabinet) may expose operators to physical injury while replacing reagents and waste containers. impact: there is potential for exposure to blood borne pathogens such as hiv, hbv, and hcv.
  • Action
    Beckman Coulter sent an Urgent Product Corrective Action letter dated October 20, 2010, with a PCA Response Form (via US PostalService) to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. This letter informed the customers about the problems identified and provided an action/resolution to this issue. Beckman Coulter asked consignees to complete and return the enclosed response form within 10 days and share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation. Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees local Beckman Coulter representative

Device

UniCel DxH 800 Analyzer
  • Model / Serial
    All serial numbers, SW version 1.1.3.0
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom
  • Product Description
    UniCel DxH 800 Floor Cabinet Part Number: 723335 || The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)
  • 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