BEUDAMED
    FDA Recall Terminated

    UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: 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-0516-2020 · Initiated October 7, 2019

    Recall

    Recall Number
    Z-0516-2020
    Event Number
    84186
    Firm
    Beckman Coulter, Inc.
    FEI Number
    3000203293
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 7, 2019
    Terminated
    April 27, 2021
    Address
    11800 SW 147th Ave, Miami, FL, 33196-2500

    Description

    UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: 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

    When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results could be reported from the slide review. Erroneous results may be reported from the laboratory which may trigger unnecessary or inappropriate patient treatment.

    Action

    Consignees were notified via email and mail with an Urgent Medical Device Recall letter, dated 10/02/2019. Four consignees were notified with a letter dated 10/18/2019. The letter identified affected product, stated the issue, provided action to be taken to determine if consignee is affected, and stated that a hardware change was in progress to eliminate the issue. A response form was asked to be returned. Questions can be directed to Beckman Coulter Customer Support Center at 800-526-7694.

    Distribution

    Worldwide distribution - US Nationwide distribution and countries of Australia, Bahrain, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Egypt, Ethiopia, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Macau, Malaysia, Mayotte, Mexico, Morocco, Netherlands, New Zealand, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Vietnam.

    Quantity

    1,056 (418 US, and 638 OUS)