BEUDAMED
    FDA Recall Terminated

    N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the evaluation of the patient's immune system.

    Recall: Z-1289-2015 · Initiated January 15, 2015

    Recall

    Recall Number
    Z-1289-2015
    Event Number
    70385
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    CFN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 15, 2015
    Posted
    March 17, 2015
    Terminated
    August 17, 2016
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the evaluation of the patient's immune system.

    Reason

    Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when using some N Latex IgM reagent kit lots 44018, 44019 and 44042.

    Action

    The firm, Siemens, sent an "Urgent Medical Device Recall" letter dated January 2015 to its customers on January 13, 2015. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Discontinue use of the affected lots and discard any remaining material; Identify if IgM quotient was overestimated due to falsely low IgM results with serum sample; Reconsider patient diagnosis taking other patient data into consideration.; When other patient data does not support the result for an intrathecal IgM synthesis or inflammation, re-measurement of samples may be considered using and alternative lot. In addition, Siemens requested customers to review this letter with their Medical Director; to complete and return the attached Effectiveness Check/Product Replacement form via fax to Customer Care Center at (312) 275-7795; retain this letter with your laboratory records, and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center 800-441-9250 or email: [email protected] or your local Siemens technical support representative.

    Distribution

    Worldwide Distribution: US distribution in states of: UT , CO, CA , FL , NY , OH , NC and country of : Canada.

    Quantity

    26