Device Recall VITROS Chemistry Products LAC Slides

  • Modelo / Serial
    Multiple lots affected, with expiry dates through 22-Mar-2015
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.
  • Descripción del producto
    VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 || VITROS LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA