BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1457-2015 · Initiated March 23, 2015

    Recall

    Recall Number
    Z-1457-2015
    Event Number
    70835
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    CHI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 23, 2015
    Posted
    April 20, 2015
    Terminated
    December 18, 2015
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    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.

    Action

    Siemens issued an Urgent Medical Device Correction on March 23, 2015, notifying direct consignees about the product, problem, and action to be taken. Customers were instructed to follow the directions provided in the customer letter in the event that a Lipase outlier is observed. All customers were requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within (30) days. Field service personnel have been sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. For further questions please call (312) 275-7795.

    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