Device Recall ThermoFisher/Microgenics

  • Modèle / numéro de série
    Catalog number, Lot Numbers & Expiration Dates: CAI-XLL, CXL1301L, 31 JAN 2013;  CAI-XL1, CXL13011, 31 JAN 2013;  CAI-XL2, CXL13012, 31 JAN 2013;  CAI-XL3, CXL13013, 31 JAN 2013;  CAI-XL4, CXL13014, 31 JAN 2013;  CAI-XLS, CXL1301S, 31 JAN 2013
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Worldwide, including Germany, France, Italy and Spain.
  • Description du dispositif
    ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. || Catalog Numbers & Description: || CAI-XLL, Level L; CAI-XL1, Level 1; CAI-XL2, Level 2; CAI-XL3, Level 3; || CAI-XL4, Multi-Pack; CAI-XLS, Sample Pack;
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Microgenics Corporation, 44660 Osgood Rd, Fremont CA 94539-6410
  • Société-mère du fabricant (2017)
  • Source
    USFDA