BEUDAMED
    FDA Recall Terminated

    Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

    Recall: Z-0162-2013 · Initiated September 11, 2012

    Recall

    Recall Number
    Z-0162-2013
    Event Number
    63167
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    MOI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 11, 2012
    Posted
    October 28, 2012
    Terminated
    September 1, 2016
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

    Reason

    BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.

    Action

    Siemens sent two "URGENT FIELD SAFETY NOTICE" letters dated August and September 2012 to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. A Field Correction Effectiveness Check Form was included for customers to complete and return.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Columbia, Japan, Korea, Mexico, New Zealand, Peru, Saudi Arabia, and Spain.

    Quantity

    15,455 kits