BEUDAMED
    FDA Recall 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 · Initiated June 22, 2016

    Recall

    Recall Number
    Z-2525-2016
    Event Number
    74534
    Firm
    Siemens Healthcare Diagnostics Inc
    FEI Number
    3002637618
    Product Code
    JHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 22, 2016
    Terminated
    November 29, 2018
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637

    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.

    Action

    Siemens Healthcare issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on June 22, 2016 both in the United States and Outside the US for communication with affected customers. This notice informs customers of the issue and provides mitigation instructions. Customers are to contact Siemens Customer Care Center or their local Siemens technical support representative at 800-405-6473. Siemens Healthcare is currently developing a software update to address this issue and will be providing new information as it becomes available

    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