BEUDAMED
    FDA Recall Terminated

    Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.

    Recall: Z-1708-2015 · Initiated April 20, 2015

    Recall

    Recall Number
    Z-1708-2015
    Event Number
    71096
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JLW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 20, 2015
    Posted
    June 4, 2015
    Terminated
    December 13, 2016
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.

    Reason

    Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed results ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a Flex well.

    Action

    Siemens sent an Urgent Medical Device Recall notice, dated April 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. - Review this letter with your Medical Doctor. - Discontinue use and discard your remaining inventory of the reagent lot listed in Table 1. - Indicate your replacement product needs on the attached Field Correction Effectiveness Check form and fax to (312) 275-7795 within 30 days. Siemens will replace any unused inventory of the affected lot at no charge. We apologize for the inconvenience this situation may cause.. If you have any questions, please contact your Siemens Customer Care Center Technical Solutions at 800-441-9258, or your local Siemens technical support representative.

    Distribution

    Worldwide Distribution - Nationwide and to the countries of : Australia, Japan, New Zealand, Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Netherlands, Portugal, and Slovakia.

    Quantity

    2256