BEUDAMED
    FDA Enforcement Class II Terminated

    BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller Hinton Broth with 3% Lysed Horse Blood is used for inoculation of MicroScan MICroSTREP plus and MicroFAST panels. 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-1804-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1804-2018
    Event ID
    79800
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 23, 2018
    Initiation Date
    March 26, 2018
    Classification Date
    May 11, 2018
    Termination Date
    December 19, 2018
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232, United States

    Description

    BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller Hinton Broth with 3% Lysed Horse Blood is used for inoculation of MicroScan MICroSTREP plus and MicroFAST panels. 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 has received customer complaints of lowered minimum inhibitory concentration (MIC) for antimicrobial agents Cefaclor (Ctr) and Penicillin (P) with control organism Streptococcus pneumoniae (ATCC 49619) during quality control (QC) testing on MICroSTREP plus(R) Panel Type 1 hydrated with Mueller-Hinton Broth with 3% lysed horse blood part number B1015-25 lot number 1005986140.

    Code Info

    Lot Number 1005986140, Expiration date April 1, 2018

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Canada, Kuwait, South Korea and Saudi Arabia.

    Quantity

    523 boxes