BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068

    Recall: Z-0613-2016 · Reported January 13, 2016

    Enforcement

    Recall Number
    Z-0613-2016
    Event ID
    72570
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 13, 2016
    Initiation Date
    November 11, 2015
    Classification Date
    January 7, 2016
    Termination Date
    September 23, 2016
    Address
    2 Edgewater Dr, N/A, Norwood, MA, 02062-4637, United States

    Description

    Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068

    Reason

    Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

    Code Info

    Lot Numbers: 245138002, 245152002, 245215002, 245262002

    Distribution

    Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.

    Quantity

    1051