BEUDAMED
    FDA Enforcement Class II Terminated

    Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.

    Recall: Z-1633-2016 · Reported May 18, 2016

    Enforcement

    Recall Number
    Z-1633-2016
    Event ID
    73442
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 18, 2016
    Initiation Date
    February 9, 2016
    Classification Date
    May 10, 2016
    Termination Date
    June 12, 2018
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.

    Reason

    Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days.

    Code Info

    Lot # EB6064

    Distribution

    Worldwide distribution and US including Puerto Rico and to the states of : TX, FL, CA, LA, DC, GA, IL, AR, WI, MI and MD.

    Quantity

    394