BEUDAMED
    FDA Recall Terminated

    Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012 This method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

    Recall: Z-1739-2011 · Initiated November 30, 2010

    Recall

    Recall Number
    Z-1739-2011
    Event Number
    57366
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    LCD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 30, 2010
    Posted
    March 21, 2011
    Terminated
    March 19, 2013
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012 This method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

    Reason

    False elevation of Dimension Vista(R) Gentamicin results for patients and QC when prior reagent aspirated by the reagent probe is any of the following plasma protein methods: ASL, B2MIC, B2MU, CRP,CYSC, HCYS, hcCRP, IGE, IGG3, IGG4, RF, and STFR resulting in inappropriate patient treatment.

    Action

    Siemens Healthcare Diagnostics, Inc. sent an Urgent Field Safety Notice letter dated November, 2010, to all affected customers. Customers were requested to run GENT on a Dimension Vista(R) system that does not run the listed plasma protein methods. Instructions were provided for disabling methods on the instrument to prevent inadvertently testing Gent along with plasma protein methods. Customers were instructed to : Forward the notification to anyone to whom they may have distributed the product. Complete and return the Field Correction Effectiveness Check Form to Siemens Healthcare Diagnostics at (302) 631-8467. For further information contact Siemens Technical Solutions Center at 1-800-441-9250 or their local Siemens representative.

    Distribution

    Nationwide Distribution including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

    Quantity

    N/A