Device Recall Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay

  • Modèle / numéro de série
    Lot #s: 230347002, 230340002, 230333002, 230326002, 230319002, 230312002, 230305002, 230298002, 230284002, 230277002, 230270002, 230263002, 230256002, 230250002, 230242002, 230236002, 230227002, 230214002, 230207002, 230201002 and 230200002.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: AL, AK, AZ, AR, CA, CO, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.Product was distributed to foreign accounts in Algeria, Armenia, Australia, Austria, Bahrain, Bangladesh,Belgium, Bosnia & Herzegovina, Canada, Canary Islands, Czech Republic, Cyprus, Croatia, Denmark, Finland, France, Germany, Great Britain, Greece, Guadeloupe, Indonesia, India, Israel, Ireland, Italy, Japan, Libya, Malaysia, Morocco, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Arab Emirates.
  • Description du dispositif
    Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay || The Stratus(R) CS Acute CareTM Troponin I method (CTNI) is an in vitro diagnostic test for the measurement of cardiac Troponin I in heparinized plasma. Cardiac Troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI). Cardiac Troponin I can also be used as an aid in the risk stratification of patients with acute coronary syndromes (ACS) with respect to their relative risk of mortality.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Société-mère du fabricant (2017)
  • Source
    USFDA