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
    58308
  • Event Risk Class
    Class 2
  • Event Number
    Z-2157-2011
  • Event Initiated Date
    2011-02-11
  • Event Date Posted
    2011-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98960
  • 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 because: the handheld barcode scanner does not read barcode labels using nw 7 symbology. impact: specimens with nw7 labels cannot be read by the handheld scanner.
  • Action
    Beckman Coulter initiated a Product Corrective Action (PCA) letter with attached Recall Response Form sent via US Postal Service on February 11, 2011 to all customers who have the affected instruments. Consignees were informed of the reasons for recall, products affected and resolution for these issues would be corrected in a future release(s) for the DxH 800; but were also asked to take the following actions: If they use NW7 bar code symbiology, the labels can be read using one of the following methods: - At the single-tube presentation station (using the internal bar code scanner) - Enter the bar code information manually at the user interface of the single-tube station - Use cassette presentation. Consignees were requested to complete and return the enclosed Response Form within ten (10) days and to share this information with their laboratory staff and retain this notification as part of their Quality System documentation. If consignees have transferred ownership or location of the analyzer(s) to another laboratory, they were requested to provide a copy of the letter to that party. For questions concerning this notice, consignees were told to contact Beckman Coulter Customer Service at 800526- 7694 in the United States or Canada, or contact their local Beckman Coulter representative.

Device

Device Recall UniCel DxH 800 Coulter Cellular Analysis System
  • Model / Serial
    All Serial Numbers are affected.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia ,Belgium, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, and the United Kingdom
  • Product Description
    UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 || 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 a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).
  • 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