BEUDAMED
    FDA Recall Terminated

    Clinical Chemistry Phenobarbital, list number 1E08

    Recall: Z-1118-2013 · Initiated November 16, 2012

    Recall

    Recall Number
    Z-1118-2013
    Event Number
    63945
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    DLZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 16, 2012
    Posted
    April 15, 2013
    Terminated
    June 18, 2013
    Address
    1921 Hurd Dr, Irving, TX, 75038-4313

    Description

    Clinical Chemistry Phenobarbital, list number 1E08

    Reason

    Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay is d 7% Total CV%; however, internal testing confirmed CVs up to approximately 12% for in-date reagent lots over five months old. Although lot 52803UN12 is now expired, it exhibit

    Action

    Abbott Laboratories sent an Immediate Action Required Product Recall letter dated November 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use and destroy any remaining inventory of the affected product in accordance with their institution's policies and procedures, order replacement lot 27426UN12 which will expire 18 DEC 2012, and is the only lot currently available (Additional lots will be available in December and January), and complete and return the enclosed Customer Reply Form. If lots were forwarded to another laboratory, a copy of the letter should be forwarded to them. For questions regarding this recall call 1-877-4ABBOTT. For customers outside of the US they should contact their local area Customers Service.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Internationally distributed to Argentina, Australia, Austria, Bahamas, Brunei, Canada, Chile, Curacao, Denmark, France, Germany, Greece, Ireland, Italy, Lebanon, Mexico, Netherlands, Norway, Oman, Paraguay, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, South Korea, Spain, Switzerland, Turkey, and United Kingdom.

    Quantity

    1289