BEUDAMED
    FDA Enforcement Class II Terminated

    Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

    Recall: Z-0801-2015 · Reported December 24, 2014

    Enforcement

    Recall Number
    Z-0801-2015
    Event ID
    69718
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 24, 2014
    Initiation Date
    October 27, 2014
    Classification Date
    December 12, 2014
    Termination Date
    March 10, 2017
    Address
    511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States

    Description

    Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

    Code Info

    Catalog #'s: 1) LSKTI1 and 2) LSKTI1(D); Siemens Material Number (SMN): 1) 10642238 (US) and 2) 10381014 (OUS); Lot Numbers: 319, 321, 322, 323 and D319, D321 and D322.

    Distribution

    Worldwide Distribution: US distribution in states of: CO, FL, MN, MT, and NY; and countries of: Algeria, Argentina, Bolivia, Brazil, Bulgaria, Chile, Columbia, Czech Republic, Ecuador, Egypt, Germany, Hungary, India, Italy, Lithuania, Latvia, Pakistan, Poland, Romania, Russian Fed., Serbia, South Africa, Slovakia, Thailand, Tunisia, and Uruguay.

    Quantity

    3,622 kits (3,572 domestic and 50 internationally)