BEUDAMED
    FDA Enforcement Class II Terminated

    MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.

    Recall: Z-0501-2015 · Reported December 10, 2014

    Enforcement

    Recall Number
    Z-0501-2015
    Event ID
    69670
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microgenics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 10, 2014
    Initiation Date
    October 20, 2014
    Classification Date
    December 3, 2014
    Termination Date
    March 30, 2015
    Address
    46500 Kato Road, N/A, Fremont, CA, 94538, United States

    Description

    MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.

    Reason

    MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32 (BNP-32).

    Code Info

    Model No.: CAI-XL1; Lot Number: CXL16011, Exp. Date: 2016-01-31.

    Distribution

    Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AR, AZ, CA CO, CT, DE, FL GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY., and the countries of Australia, Canada, China, Germany, Guam, Hong Kong and Taiwan.

    Quantity

    2135 vials.