BEUDAMED
    FDA Recall Terminated

    UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear

    Recall: Z-2692-2016 · Initiated August 4, 2016

    Recall

    Recall Number
    Z-2692-2016
    Event Number
    74875
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 4, 2016
    Terminated
    October 6, 2016
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear

    Reason

    Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire.

    Action

    Beckman Coulter sent an Urgent Medical Device recall letter dated August 4, 2016, to all affected customers to inform them that the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding the recall notice were instructed to contact Beckman Coulter Customer Support Center: http://www.beckmancoulter.com/customersupport/support; 800-526-7694 in the United States and Canada; and outside the United States and Canada, are instructed to contact their local Beckman Coulter Representative.

    Distribution

    Worldwide Distribution to US (nationwide) and Internationally to Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Japan, Kuwait, Malaysia, Mayotte, Mexico, New Zealand, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, and Vietnam.

    Quantity

    759 units total (358 units in US)