BEUDAMED
    FDA Recall Terminated

    ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagnostics Corporation Indianapolis, IN.

    Recall: Z-2386-2010 · Initiated February 5, 2010

    Recall

    Recall Number
    Z-2386-2010
    Event Number
    54624
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    LAN
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    February 5, 2010
    Posted
    September 8, 2010
    Terminated
    November 1, 2010
    Address
    9115 Hague Road, Indianapolis, IN, 46256

    Description

    ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagnostics Corporation Indianapolis, IN.

    Reason

    The N-acetylprocainamide reagent lot 14456200 shows an incorrect expiration date of 7/31/2011. The correct expiration date for the lot is 1/31/2011.

    Action

    Roche issued an "Urgent Medical Device Removal" letter dated February 2010 to consignees identifying the issue and affected product. Customers were requested to complete the attached form and return in to the firm to obtain replacement product. After receipt of replacement reagent, the customer should discard the affected product product. If unaffected lots are not available, customers may use the affected lot until replacement product is received. Use of the affected product before the corrected expiration date of January 31, 2011 should not produce erroneous test results. Roche Diagnostics Technical Support can be contacted at 1-800-428-2336.

    Distribution

    Nationwide Distribution: USA states of AL, CT, NY, PA, and TX.

    Quantity

    40 kits