Events

Recall of 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
    58016
  • Event Risk Class
    Class 2
  • Event Number
    Z-1977-2011
  • Event Initiated Date
    2010-10-20
  • Event Date Posted
    2011-04-13
  • 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=97978
  • 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
    There is a possibility that a specimen could be diluted if a user requests diluent dispense while specimens are being automatically processed in cassette presentation. the dilution may cause erroneous results. impact: erroneous results from a diluted specimen could impact clinical decision making in cases such as blood transfusion, chemotherapy or antibiotic administration- particularly for popu.
  • Action
    The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" (PCA) letter with PCA Response Form (via US Postal Service for US customers) dated October 20, 2010, to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter describes the product, problem and the following actions to be taken. The customers were instructed to remove all cassettes from the mix station prior to initiating the Diluent Dispense function to prevent the likelihood of a specimen being diluted; do not use pre-diluted samples for RETIC counts; verify that their information Technology personnel are aware that the Body Fluids data string is only transmitted to the LIS using the US numeric separators and the Body Fluid results are properly validated at the LIS. This will be corrected in a future version; use the lip on the reagent drawer as shown in the picture above; avoid touching the drawer slides while replacing containers; clean all spills promptly to reduce the risk of exposure to blood borne pathogens; complete and return enclosed PRODUCT CORRECTIVE ACTION RESPONSE FORM via fax to 786-639-7500/7501/7502/7503/7503/7504; mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06, 11800 S.W. 147th Avenue, PO Box 169015, Miami, FL 33116-9015 or email to: Regulatory.Notifications@beckmancoulter.com, and share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If you have any questions regarding this PCA, contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees/customers local Beckman Coulter representative.

Device

UniCel DxH 800 Coulter Cellular Analysis System
  • 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 countries including: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 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: - 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