Device Recall Vina Green(tm) Chromogen Kit

  • Model / Serial
    Catalog number VG807H, lot 060211 and 101211; expiration 5/2013; Catalog number VG807S, lot 053111, 060211; both with expiration of 5/2013; lot 101211, Expiration 8/2013.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of WI, KY, CA, GA, IN, MA, IL, MD, NC, LA. AZ, TX, NC, NJ, MO, NY, PA, OH, DC, MI, WA, and CO, and the countries of Canada, Sweden, Germany, Italy, and Switzerland.
  • Product Description
    BioCare Medical Vina Green Chromogen Kit; 25 mL, 100ml IVD. Kits include: Vina Green Chromogen 1. 0 mL; Vina Green Buffer, 25 mL and Vina Green Dropper Bottle. BioCare Medical, Concord, CA 94520. || Vina Green is intended for both IHC and ISH applications including HPV, CMV, EBV, Kappa, TTF-1, Ki-67 and other targets/antigens such as blood and lymphatic vessels and basal and myoepithelial cells.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biocare Medical Llc, 4040 Pike Ln, Concord CA 94520
  • Manufacturer Parent Company (2017)
  • Source
    USFDA