BEUDAMED
    FDA Recall 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 · Initiated September 10, 2015

    Recall

    Recall Number
    Z-0108-2016
    Event Number
    72176
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    LTT
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    September 10, 2015
    Posted
    October 7, 2015
    Terminated
    January 22, 2016
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    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.

    Action

    Beckman Coulter Inc. sent an Urgent Medical Device Recall letter dated Setember 10, 2015 to all customers who purchased the MICroSTREP plus 1 and MICroSTREP plus 2. The letter identified the affected products, problem and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions regarding the notice, are instructed to contact their Customer Support Representative:website: http://www.beckmancoulter.com or by phone: 1-800-677-7226 in the United States and Canada.

    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)