BEUDAMED
    FDA Recall Terminated

    Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay

    Recall: Z-0181-2014 · Initiated August 30, 2013

    Recall

    Recall Number
    Z-0181-2014
    Event Number
    66267
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    DLZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 30, 2013
    Posted
    November 7, 2013
    Terminated
    August 27, 2014
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay

    Reason

    Imprecision with certain lots

    Action

    Siemens sent an Urgent Medical Device Recall letter dated August 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use of the affected product. Siemens will replace unused affected product at no charge. For replacements customers were instructed to incude this information on the Effectiveness Check form included with the letter. The Effectiveness Check form must be returned even if no replacement reagents are needed. The recall letter was to be retained with customers laboratory records and forwarded to those who may have received this product. Customers with questions were instructed to contact Siemens Technical Solutions or their Siemens technical support representative. For questions regarding this recall call 800-441-9250.

    Distribution

    Worldwide Distribution - USA (nationwide) and Mexico.

    Quantity

    4963