BEUDAMED
    FDA Recall Terminated

    Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.

    Recall: Z-0131-2015 · Initiated April 7, 2014

    Recall

    Recall Number
    Z-0131-2015
    Event Number
    67987
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    CHI
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    April 7, 2014
    Posted
    October 28, 2014
    Terminated
    April 1, 2015
    Address
    1921 Hurd Dr, Irving, TX, 75038-4313

    Description

    Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.

    Reason

    Package inserts have incorrect SmartWash parameters for Triglyceride.

    Action

    Firm issued a Product Correction Letter to all Lipase reagent customers who received lots 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, and 44930UQ11. The letter identified the affected product and provided an explanation of the problem, as well as, the patient impact and actions to be taken. The Product Correction Letter provided guidance for the laboratory to correctly configure the Architect cSystem's Lipase assay parameters. Customers are to retain a copy of the letter for their lab records, and forward a copy to any laboratories that the product was further distributed to. Questions should be directed to Customer Service at 1-877-4ABBOTT or your local customer service for customers outside of the US.

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Dominican Republic, Egypt, Estonia, France, Germany, Greece, Guatemala, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turks and Caicos, Turkey, Uganda, United Arab Emirates, United Kingdom, and Uruguay.

    Quantity

    11916 units