BEUDAMED
    FDA Enforcement Class II Terminated

    Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.

    Recall: Z-2241-2016 · Reported July 27, 2016

    Enforcement

    Recall Number
    Z-2241-2016
    Event ID
    74468
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CSL Behring GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2016
    Initiation Date
    May 17, 2016
    Classification Date
    July 19, 2016
    Termination Date
    February 7, 2018
    Address
    Emil-von-Behring-Str. 76, N/A, Marburg, N/A, N/A, Germany

    Description

    Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.

    Reason

    Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.

    Code Info

    Lot Number 15243MA Mfg Date: 08/31/2015 Exp Date: 05/31/2016 Lot Number 15243MB Mfg Datge: 08/31/2015 Exp Date: 05/31/2016

    Distribution

    Distributed to: AL, AR, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI, WV

    Quantity

    898 units