BEUDAMED
    FDA Recall Terminated

    MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests. MESOMARK is an enzyme linked immunosorbent assay (ELISA) for the quantitative measurement of Soluble mesothelin Related Peptides (SMRP) in human serum. Measurement of SMRP may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. MESOMARK values must be interpreted in conjunction with all other available clinical and laboratory data.

    Recall: Z-1606-2011 · Initiated July 29, 2010

    Recall

    Recall Number
    Z-1606-2011
    Event Number
    56427
    Firm
    Fujirebio Diagnostics, Inc.
    FEI Number
    2521625
    Product Code
    OAW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 29, 2010
    Posted
    March 8, 2011
    Terminated
    July 5, 2012
    Address
    201 Great Valley Pkwy, Malvern, PA, 19355-1308

    Description

    MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests. MESOMARK is an enzyme linked immunosorbent assay (ELISA) for the quantitative measurement of Soluble mesothelin Related Peptides (SMRP) in human serum. Measurement of SMRP may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. MESOMARK values must be interpreted in conjunction with all other available clinical and laboratory data.

    Reason

    presence of material attached to the bottom of some wells in places visible to the naked eye, which caused an overestimation of the sample.

    Action

    Notification dated 7/7/10 was sent to the customer via e-mail and FedEx Priority Overnight. FUJIREBIO Diagnostics, Inc. sent an URGENT PRODUCT CORRECTION NOTIIFICATION letter dated July 7, 2010, to all affected customers via e-mail and FedEx Priority Overnight. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue using MESOMARK kit. Lot 57K04510 and discard any remaining inventory. Complete and return the attached Confirmation of Receipt form upon receipt of this notification, no later than July 30, 2010. Notify your ordering physician or health care provider as appropriate. For questions regarding this recall call 877-861-7246 or 610-240-3800.

    Distribution

    Nationwide Distribution including UT

    Quantity

    42 kits