Device Recall OPTI LION EPlus

  • Modèle / numéro de série
    Lot Numbers: 701800, 706800, 710801, 711800, 711801, 712800, 713800, 714800, 714801, 714802, and 718800
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA, Australia, Chile, China, Egypt, France, Great Britain, Guatemala, Indonesia, Italy, Korea, Lebanon, Mauritania, Morocco, Nepal, Russia, South Africa, Sweden, Tanzania, Thailand, and Venezuela.
  • Description du dispositif
    OPTI¿ LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Opti Medical Systems Inc, 235 Hembree Park Dr Ste 200, Roswell GA 30076-5700
  • Source
    USFDA

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot numbers 038811 and 102812
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-- USA (nationwide) including states of CA and VA, and countries of India, Lebanon, Philippines, Sweden, Venezuela and Vietnam.
  • Description du dispositif
    OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). || Cassettes are consumables used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma. . Cassettes contain one-time use sensors that are used with the OPTI-LION analyzer to perform in-vitro measurements of electrolytes. OPTI LION E-Plus Cassettes are supplied in boxes of 25 and may only be used with the OPTI LION Electrolyte Analyzer.
  • Manufacturer