BEUDAMED
    FDA Enforcement Class II Terminated

    Clinical Chemistry Phenobarbital, list number 1E08

    Recall: Z-1118-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1118-2013
    Event ID
    63945
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Laboratories, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    November 16, 2012
    Classification Date
    April 15, 2013
    Termination Date
    June 18, 2013
    Address
    1921 Hurd Dr, N/A, Irving, TX, 75038-4313, United States

    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

    Code Info

    Lot Numbers 52803UN12, 62299UN12, and 85773UN12

    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