BEUDAMED
    FDA Recall Terminated

    Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.

    Recall: Z-1647-2014 · Initiated March 19, 2014

    Recall

    Recall Number
    Z-1647-2014
    Event Number
    67787
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    MKW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 19, 2014
    Posted
    May 21, 2014
    Terminated
    August 10, 2015
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.

    Reason

    A complaint was received of Dimension Vista CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample Container. The under-recovery that has been observed is 18 to 44%. In March 2014, Siemens recalled due to the complaint received of Dimension Vista CSA and CSAE reporting under-recovery of cyclosporine when patient samples are run from the Small Sample C

    Action

    Siemens sent an Urgent Medical Device Correction letter dated March 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use the SSC with patient samples when running CSE or CSAE. Siemens also recommended a look back at previously generated CSA or CSAE results if the patient samples have been run from the SSC and that the content of this letter should be discussed with the Medical Director. Customers were asked to complete the attached form and fax it to (302) 631-8467. For questions regarding this recall call 800-441-9250.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Belgium, Switzerland, Germany, Spain, France, Great Britain, Italy, Saudi Arabia, Australia, and Japan.

    Quantity

    4175