Device Recall ADVIA Centaur Vitamin D Diluent 2pack

  • Modèle / numéro de série
    Lot # 80230 Expiry Date 04 May 2012
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Columbia, China, Denmark, Egypt, and Hong Kong.
  • Description du dispositif
    Siemens ADVIA Centaur Vitamin D Diluent 2-pack, || Reference 10494100 || in vitro diagnostic use in the quantitative determination of total || 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systems || The ADVIA Centaur Vitamin D Total (Vit D) assay is for in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systems. The ADVIA Centaur Vit Assay is intended as an aid in the determination of vitamin D insufficiency. The ADVIA Centaur Vitamin D Diluent 2-pack is used on board the ADVIA Centaur systems to perform automatic and system-performed dilutions fro Vitamin D assay.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Société-mère du fabricant (2017)
  • Source
    USFDA