BEUDAMED
    FDA Recall Terminated

    IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.

    Recall: Z-2841-2016 · Initiated April 15, 2016

    Recall

    Recall Number
    Z-2841-2016
    Event Number
    73995
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    CFL
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    April 15, 2016
    Posted
    September 16, 2016
    Terminated
    April 20, 2017
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.

    Reason

    24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment solution when using the pretreatment solution (LGFA) contained in the kit.

    Action

    On April 15, 2016, Siemens Healthcare Diagnostics Inc. distributed Urgent Medical Device Correction notices to their domestic customers and Urgent Field Safety Notices to their internationally customers via courier service. Customers are advised to take the following four actions: 1) To continue using IGF-I kit lot 411 and the associated pretreatment solution lot 055 to report patient results, ensure the IGF-I pretreatment solution is allowed to incubate with the patient sample for a minimum of 24 minutes prior to processing on the IMMULITE/IMMULITE 1000 systems. 2) Complete and return the Effectiveness Check Form attached to the letter within 30 days. 3) Please review the letter with your Medical Director. 4) If you have received any complaints of illness or adverse events associated with the product, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. If customers have further distributed the product, please retain the letter with your laboratory records, and forward to those who may have received this product.

    Distribution

    Domestic: IL, FL, NY, OH, LA, MO, MA; International: Canada, others will be inserted

    Quantity

    525 units