BEUDAMED
    FDA Enforcement Class II Terminated

    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003

    Recall: Z-1109-2017 · Reported February 8, 2017

    Enforcement

    Recall Number
    Z-1109-2017
    Event ID
    76159
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Immuno-Mycologics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 8, 2017
    Initiation Date
    December 27, 2016
    Classification Date
    January 27, 2017
    Termination Date
    March 8, 2017
    Address
    2700 Technology Pl, N/A, Norman, OK, 73071-1127, United States

    Description

    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003

    Reason

    The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive results.

    Code Info

    161028133653JH, 161003111544KH, and 161007105036JG

    Distribution

    Nationwide throughout the US

    Quantity

    630 units