BEUDAMED
    FDA Enforcement Class II Terminated

    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.

    Recall: Z-2409-2018 · Reported July 18, 2018

    Enforcement

    Recall Number
    Z-2409-2018
    Event ID
    80284
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Immuno-Mycologics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 18, 2018
    Initiation Date
    March 30, 2018
    Classification Date
    July 10, 2018
    Termination Date
    May 21, 2020
    Address
    2700 Technology Pl, Norman, OK, 73071-1127, United States

    Description

    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.

    Reason

    Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results

    Code Info

    Lot/Serial Numbers: L102802 and L103012

    Distribution

    On March 30, 2018, IMMY began issuing URGENT MEDICAL DEVICE RECALL notices to customers via email. Customers were advised on how to recognize that the device has failed. The following are Actions to be taken by the customer/user: " You may continue using the affected lots. Any testing performed on defective strips should be considered invalid and should be repeated. " Please immediately notify lab personnel who are running the test to look for defective strips (as seen by fast wicking and/or very weak control lines). " Please immediately complete the Acknowledgement and Receipt Form even if you do not have any affected stock remaining and submit via email to: [email protected]. " Ensure relevant staff members are informed of this recall, including relevant clinicians. " If you have supplied any potentially affected product to another organization, please advise that organization of this recall and notify IMMY. " In case product is in transit, display this letter in a prominent place for one month. Should you need a replacement kit, you will need to return your affected inventory. Instructions will be provided by customer service on how to return kits to IMMY. If you have any questions, contact IMMYs Quality Assurance Department by calling 1-405-360-4669 Monday through Friday 8:30 AM to 5:00 PM Central Standard Time.

    Quantity

    875 units