BEUDAMED
    FDA Recall Terminated

    ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591.

    Recall: Z-1119-2008 · Initiated January 12, 2008

    Recall

    Recall Number
    Z-1119-2008
    Event Number
    46346
    Firm
    Siemens Medical Solutions Diagnostics
    FEI Number
    1219913
    Product Code
    LOL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 12, 2008
    Posted
    May 6, 2008
    Terminated
    June 20, 2012
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591.

    Reason

    Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay.

    Action

    Siemens issued a Urgent Field Safety Notiifcation (078D0709-01) to all Siemens Diagnostics Branches on 1/12/08 for communication to their customers. This Customer Bulletin/Urgent Field Safety Notification advises the customer of the problem and the actions to be taken to mitigate risk. A Confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action.

    Distribution

    Worldwide Distribution - USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Chile, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.

    Quantity

    49,533