BEUDAMED
    FDA Recall Terminated

    MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel.

    Recall: Z-0768-2017 · Initiated October 25, 2016

    Recall

    Recall Number
    Z-0768-2017
    Event Number
    75576
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    OUG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 25, 2016
    Posted
    December 15, 2016
    Terminated
    May 1, 2017
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel.

    Reason

    Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. The issue could cause workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels.

    Action

    An Urgent Medical Device Recall letter dated 10/25/16 was sent to all their customers to inform them that Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. Customers are informed that the issue could cause WalkAway workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels. The letter informs the customers of the actions to be taken and the resolution for the product on recall. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact their Customer Support representative: http://www.beckmancoulter.com or call 1-800-677-7226, option 1 in the United States.

    Distribution

    Worldwide Distribution -- United States and Mexico.

    Quantity

    131 units total (130 units in US)