Events

Rappel de Device Recall Vina Green(tm) Chromogen Kit

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Biocare Medical Llc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    61395
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1392-2012
  • Date de mise en oeuvre de l'événement
    2012-03-13
  • Date de publication de l'événement
    2012-04-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107990
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Immunohistochemistry reagents and kits - Product Code NJT
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Biocare Medical Llc, 4040 Pike Ln, Concord CA 94520
  • Société-mère du fabricant (2017)
    Biocare Medical LLC
  • Source
    USFDA