Events

Rappel de IsEBVVCA IgG

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 Diamedix Corporation.

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
    73694
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1687-2016
  • Date de mise en oeuvre de l'événement
    2014-10-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144776
  • 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
    Antiserum, cf, epstein-barr virus - Product Code GNP
  • Cause
    A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
  • Action
    The firm, Diamedix, sent letters dated October 14, October 20 and December 5, 2014 to its customers directly informing them of the correction action. Notification of all domestic customers via Certified Mail. Notification fo the international customers via Federal Express and/or e-mail. With the letter, a replacement bottle of Sample B Diluent was sent and the customer was advised to discard any unused bottles of affected product. New lot number labels were provided to identify kits with the replacement Sample B Diluent. Customers with questions were told they could contact Diamedix Technical Services (1-800-327-4565) if they had any questions or required any additional guidance regarding the correction.

Device

IsEBVVCA IgG
  • Modèle / numéro de série
    Lot # 51104, Catalog # 720-640 Expiration Date August 31, 2015
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US nationwide including states of: AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Puerto Rico. and Country of: ITALY.
  • Description du dispositif
    Diamedix Is-EBV-EA-D IgG Test Kit || Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
  • Manufacturer
    Diamedix Corporation

Manufacturer

Diamedix Corporation
  • Adresse du fabricant
    Diamedix Corporation, 14100 Nw 57th Ct, Miami Lakes FL 33014-3107
  • Société-mère du fabricant (2017)
    Diamedix, Inc.
  • Source
    USFDA