BEUDAMED
    FDA Enforcement Class II Terminated

    ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.

    Recall: Z-1312-2018 · Reported April 11, 2018

    Enforcement

    Recall Number
    Z-1312-2018
    Event ID
    79444
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Phadia US Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 11, 2018
    Initiation Date
    December 18, 2017
    Classification Date
    April 5, 2018
    Termination Date
    March 27, 2019
    Address
    4169 Commercial Ave, N/A, Portage, MI, 49002-9701, United States

    Description

    ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.

    Reason

    The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.

    Code Info

    Lots 990DS, Exp 2017.12.31 990DT, Exp 2018.01.31 990DW, Exp 2018.03.31 990DX, Exp, 2018.05.31 990DY

    Distribution

    Nationwide Distribution

    Quantity

    950 total