BEUDAMED
    FDA Recall Terminated

    UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a tabletop or with a floor stand. The DxH 600 is available as an analyzer for use on a tabletop only.

    Recall: Z-0147-2014 · Initiated September 24, 2013

    Recall

    Recall Number
    Z-0147-2014
    Event Number
    66382
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 24, 2013
    Posted
    November 4, 2013
    Terminated
    April 21, 2014
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a tabletop or with a floor stand. The DxH 600 is available as an analyzer for use on a tabletop only.

    Reason

    Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 600 Coulter Cellular Analysis System (PN B23858) because the company's internal investigation indicates that specific lots of check valves used in several locations within the DxH 800 and DxH 600 systems may fail. A failure may result in an air or liquid leak at the VCS Waste Chamb

    Action

    The firm, Beckman Coulter, sent an "URGENT PRODUCT CORRECTION" letter dated September 12, 2013, its customers. The letter includes the products descriptions and codes, issue, impact, action, resolution, instructions to the customers, and contact information. The customers were instructed to review the three samples analyzed prior to error message,if you experience a "Vent/overflow chamber detected overflow' error; to avoid physical contact with a possible leak by continuing to use personal protective equipment as recommended in the Instructions for Use and by national regulations; share this information with your staff and retain this notification as part of your Quality System documentation; if you have forwarded any of the affected products, provide them a copy of this letter; and to complete and return the enclosed RESPONSE FORM within 10 days via fax to: 786-639-7500 /7501/7502/7504; email: [email protected] (note: please include "DxH system check valve letter dated 09/12/2013" in email subject field) and/or by mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06, 11800 S.W. 147th Avenue, PO Box 169015, Miami Fl 36116-9015. . Your service representative will contact you to schedule an on-site visit for check valve inspection and replacement of any affected valves. If you have any questions concerning this notification, please contact our Customer Support Center: via our website, http://www.beckmancoulter.com/customersupport/support, via phone, call 800-526-7694 in the United States and Canada, and Outside US and Canada, contact your local Beckman Coulter Representaitive.

    Distribution

    Worldwide distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Macao, Netherlands, New Zealand, Panama, Poland, Portugal Qatar, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Thailand, Trindad and Tobago, Turkey, United Arab Emirates, and United Kingdom. .

    Quantity

    1,025 units