BEUDAMED
    FDA Enforcement Class III Terminated

    Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343, Manufactured by: Beckman Coulter Biomedical GmbH Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes.

    Recall: Z-0357-2019 · Reported November 7, 2018

    Enforcement

    Recall Number
    Z-0357-2019
    Event ID
    80434
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    November 7, 2018
    Initiation Date
    May 24, 2018
    Classification Date
    October 31, 2018
    Termination Date
    December 8, 2022
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343, Manufactured by: Beckman Coulter Biomedical GmbH Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes.

    Reason

    Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes. When printing consecutively numbered tube labels using this optional Barcode Counter function, the system incorrectly converts numbers with consecutive multiple zeroes in the middle, potentially leading to wrong barcode IDs. The firm reports that this does not affect automated label creation or reprinting of individual labels and that no other system functions are affected.

    Code Info

    v4.2.1 (and 4.2, discontinued)

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Algeria, Argentina, Austria, Belgium, Brazil, Chile, China, Czech Republic, Denmark ,France, Germany, Greece ,Hong Kong, India, Ireland, Israel, Italy ,Republic of Korea, Lebanon, Lithuania ,Malaysia, Netherlands, Poland, Portugal , Qatar, Romania, Russian Federation, Saudi Arabia ,South Africa , Spain, Sweden, Taiwan, Turkey , and United Kingdom.

    Quantity

    29