BEUDAMED
    FDA Recall 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 · Initiated May 17, 2016

    Recall

    Recall Number
    Z-2241-2016
    Event Number
    74468
    Firm
    CSL Behring GmbH Emil-von-Behring-Str. 76 Marburg Germany
    FEI Number
    3003098680
    Product Code
    LPS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 17, 2016
    Terminated
    February 7, 2018

    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.

    Action

    Siemens mailed an Urgent Medical Device Recall to all customers who received the affected lots notifying them of the following: 1) Discontinue use and discard any remaining inventory of the affected lots, and 2) Indicate their replacement product needs within 30 days.

    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