Device Recall IMMULITE/IMMULITE Turbo 1000 CKMB

  • Modèle / numéro de série
    kit lot 316, 318
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    IMMULITE¿/IMMULITE¿ Turbo 1000 CK-MB LSKCP --- Catalog number: LSKCP1 (100 tests), LSKCP5 (500 tests) --- Test code: RCK Color: Orange. || For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA