Events

Recall of Device Recall Vina Green(tm) Chromogen Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biocare Medical Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61395
  • Event Risk Class
    Class 2
  • Event Number
    Z-1392-2012
  • Event Initiated Date
    2012-03-13
  • Event Date Posted
    2012-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107990
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Immunohistochemistry reagents and kits - Product Code NJT
  • Reason
    Reports of sporadic failure of specific lots of vina green chromogen kit, either through crystal formation that obscures positive staining, color not right, or a complete fading of staining by the chromogen.
  • Action
    "Medical Device Recall Notification" letters were sent on March 13, 2012 to all direct account. Letters informed customers of the reason for recall and the specific lots and catalog numbers involved, along with the reason for recall, how to identify the recalled product, and the actions to be taken. Customers were to immediately discontinue use of the affected product lot(s). They should dispose of the product according to national, state, and local laws and regulations. The enclosed Return Response Form should be completed and returned. Customers will be credited upon receipt of the Response Form.

Device

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
    Hematology and Pathology Devices
  • 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
    Biocare Medical Llc

Manufacturer

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