BEUDAMED
    FDA Enforcement Class II Terminated

    Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis

    Recall: Z-2040-2016 · Reported June 29, 2016

    Enforcement

    Recall Number
    Z-2040-2016
    Event ID
    74113
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Immuno-Mycologics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 29, 2016
    Initiation Date
    May 9, 2016
    Classification Date
    June 20, 2016
    Termination Date
    January 10, 2017
    Address
    2700 Technology Pl, N/A, Norman, OK, 73071-1127, United States

    Description

    Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis

    Reason

    The device was found to have bacterial contamination.

    Code Info

    Lot 111WH3

    Distribution

    Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.

    Quantity

    467 units