BEUDAMED
    FDA Enforcement Class II Terminated

    Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531

    Recall: Z-2525-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2525-2016
    Event ID
    74534
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 17, 2016
    Initiation Date
    June 22, 2016
    Classification Date
    August 11, 2016
    Termination Date
    November 29, 2018
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637, United States

    Description

    Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531

    Reason

    Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibration and quality control (QC) status when a TestPak is due to expire within 48 hours.

    Code Info

    All software versions and serial numbers

    Distribution

    Worldwide Distribution -- USA, U.A.E., Algeria, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Canada, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Namibia, P.R. China, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.

    Quantity

    977 units