BEUDAMED
    FDA Recall Terminated

    CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.

    Recall: Z-1545-2014 · Initiated February 26, 2013

    Recall

    Recall Number
    Z-1545-2014
    Event Number
    67930
    Firm
    Siemens Healthcare Diagnostics Inc
    FEI Number
    3002637618
    Product Code
    KQO
    Status
    Terminated
    Root Cause
    Reprocessing Controls
    Initiated
    February 26, 2013
    Posted
    May 4, 2014
    Terminated
    May 6, 2014
    Address
    2 Edgewater Drive, Norwood, MA, 02062

    Description

    CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.

    Reason

    Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.

    Action

    On February 26, 2013, a Siemens Field Engineer from Siemens Healthcare visited customer site and disabled the Sample Interference Notes feature on the instrument.

    Distribution

    US Distribution in the state of: CA.

    Quantity

    1 unit