BEUDAMED
    FDA Enforcement Class II Terminated

    ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.

    Recall: Z-1457-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1457-2015
    Event ID
    70835
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2015
    Initiation Date
    March 23, 2015
    Classification Date
    April 20, 2015
    Termination Date
    December 18, 2015
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005, United States

    Description

    ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.

    Reason

    Siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in falsely elevated ADVIA Chemistry Lipase outlier results when running with Triglycerides, Triglycerides_2, Triglycerides_c, Cholesterol concentrated, and DLDL reagents.

    Code Info

    Catalog Number: B01-4840-01; Material Number (SMN)10311896, Lot Numbers: 318706, 332463, expiration dates 2015-06-30, 2015-08-31

    Distribution

    Worldwide Distribution - US (nationwide) Distribution and to the countries of : Thailand, Pakistan, Vatican, Guadeloupe, Reunion, French Polynesia , Serbia, Martinique, India, China, Singapore, Brazil, South Africa, Mexico, Canada, Israel, Australia, Egypt, Russian Federation, Indonesia, Rep. Korea (S) ,Unit.Arab Emir., Taiwan ,Argentina ,Chile, Malaysia ,Colombia, Peru, Kazakhstan, Paraguay, Vietnam, Algeria, Austria, Belgium, Switzerland, Cyprus, Czech Republic, Germany, Estonia, Spain, Finland, France, United Kingdom, Greece, Hungary, Italy, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Slovakia and Turkey.

    Quantity

    7814