BEUDAMED
    FDA Enforcement Class II Terminated

    MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.

    Recall: Z-0108-2016 · Reported October 14, 2015

    Enforcement

    Recall Number
    Z-0108-2016
    Event ID
    72176
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2015
    Initiation Date
    September 10, 2015
    Classification Date
    October 7, 2015
    Termination Date
    January 22, 2016
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.

    Reason

    Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.

    Code Info

    2016-01-27 2016-02-27 2016-03-26 2016-04-02 2016-04-14 2016-05-01 2016-05-15 2016-06-12

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Bahamas, Belgium, Canada, Ecuador, Germany, Italy, Republic of Korea, Mexico, Peru, Poland, Romania, Saudi Arabia, South Africa, Thailand, United Sates (including Puerto Rico), and Uruguay.

    Quantity

    5138 units total (4,360 units in US)