Device Recall COBAS Ampliprep/COBAS TaqMan HBV v2.0 USIVD COBAS Ampliprep/COBAS TaqMan HBV v2.0 CEIVD

  • Modèle / numéro de série
    Catalog number 05027012190, 05393850190, 05393850190, 05393868190 Lot #K11236, K15440, L00846, M05135, M11190, M12625, M14232, N00159, N02341, N05553, N05554, N07543, N08567
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CT, IN, MI, MN, NC, NE, NY, OR, TX, WA, and WI and the countries of Australia, Austria, Azerbaijan, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Egypt, Finland, France, Germany, Ghana, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mauritania, Mongolia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and the United Kingdom
  • Description du dispositif
    COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD; || COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Roche Molecular Systems, Inc., 1080 Us Highway 202 S, Somerville NJ 08876-3733
  • Société-mère du fabricant (2017)
  • Source
    USFDA