BEUDAMED
    FDA Recall Terminated

    IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.

    Recall: Z-1518-2014 · Initiated December 20, 2013

    Recall

    Recall Number
    Z-1518-2014
    Event Number
    67210
    Firm
    Siemens Healthcare Diagnostics
    FEI Number
    2432235
    Product Code
    JHR
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 20, 2013
    Posted
    April 25, 2014
    Terminated
    May 18, 2018
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.

    Reason

    Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.

    Action

    Urgent Medical Device Correction Letters (dated 12/20/13) and effectiveness check response forms were sent to customers on 12/20/13 via FedEx to inform them of the issue. Customers were requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Field service personnel were sent a support document describing the issue and instructing them how to deal with customer questions.

    Distribution

    Worldwide distribution.

    Quantity

    18,489 units