BEUDAMED
    FDA Recall Terminated

    Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System.

    Recall: Z-0139-2011 · Initiated August 19, 2010

    Recall

    Recall Number
    Z-0139-2011
    Event Number
    56703
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    CEM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 19, 2010
    Posted
    October 25, 2010
    Terminated
    October 26, 2010
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System.

    Reason

    High potassium content in the affected lots results in the potential for low potassium recovery for Dilution Check, QC and patient samples when run on the Dimension Vista System.

    Action

    Siemens sent an Urgent Field Safety Notice (dated "August 2010") to customers identifying the product, the problem and the action to be taken. Customers were instructed on how to continue testing until new lots of the recalled product were available and asked to complete and fax a Field Correction Effectiveness Check to 301-631-8467 to confirm receipt of the Urgent Field Safety Notice. For technical questions or concerns customers were instructed to contact the Siemens Technical Solutions Center at 800-441-9250.

    Distribution

    USA, Nationwide Distribution

    Quantity

    3,706 cartons