BEUDAMED
    FDA Recall 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 · Initiated May 9, 2016

    Recall

    Recall Number
    Z-2040-2016
    Event Number
    74113
    Firm
    Immuno-Mycologics, Inc
    FEI Number
    1627497
    Product Code
    GMJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 9, 2016
    Posted
    June 20, 2016
    Terminated
    January 10, 2017
    Address
    2700 Technology Pl, Norman, OK, 73071-1127

    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.

    Action

    Immuno-Mycologics, Inc sent an Urgent Medical Device Recall letter dated May 9, 2016, to all affected customers. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their stock and destroy affected stock on hand. Immediately complete the attached Acknowledgement and Receipt Form even if they do not have affected stock. Customers who require replacement indicate the number of vials needed in the attached Acknowledgement Form. Customers with questions were instructed to call 1-405-360-4669.

    Distribution

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

    Quantity

    467 units