BEUDAMED
    FDA Recall Terminated

    Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital

    Recall: Z-0030-2013 · Initiated July 30, 2012

    Recall

    Recall Number
    Z-0030-2013
    Event Number
    62832
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    DLZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 30, 2012
    Posted
    October 10, 2012
    Terminated
    August 27, 2014
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital

    Reason

    Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Also, if the Syva(R) Emit(R) 2000 Phenobartbital Assay (4D019UL) lots D4, D5, D6, and/or D7 as an application on AU(R) Systems is used, the issue may be experienced. Firm has found that within-run imprecison of the recalled lots when run on an AU(R) System may be higher that what would normally be obs

    Action

    Siemens sent an Urgent Field Safety notice letter dated July 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately discontinue use and discard any remaining inventory of the affected product. Customers were asked to share the content of the letter with laboratory director regarding the need to review previous Phenobarbital results, conduct patient follow up and/or repeat testing. For a no charge replacement of remaining inventory customers were instructed to contact Siemens Customer Service Center at 888-588-3916. For questions contact Siemens Technical Solutions Center at 800-227-8994.

    Distribution

    United States Nationwide Distribution in the states of: CA, FL, KS, MA, MN, MS, NM, NY, NC, OR, PA, TN, TX, UT, VA, and WA.

    Quantity

    79,744 cartons