BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1109-2017 · Initiated December 27, 2016

    Recall

    Recall Number
    Z-1109-2017
    Event Number
    76159
    Firm
    Immuno-Mycologics, Inc
    FEI Number
    1627497
    Product Code
    GMD
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    December 27, 2016
    Posted
    January 27, 2017
    Terminated
    March 8, 2017
    Address
    2700 Technology Pl, Norman, OK, 73071-1127

    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.

    Action

    Immuno sent an Urgent: Medical Device Recall Letter dated December 27, 2016, to all affected customers. All customers were notified via emails to stop using the product on December 27th and December 28th. A recall notification and response form was attached to the email. For further questions, please call (405)364-1058.

    Distribution

    Nationwide throughout the US

    Quantity

    630 units