Events

Recall of IsEBVVCA IgG

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

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
    73694
  • Event Risk Class
    Class 2
  • Event Number
    Z-1686-2016
  • Event Initiated Date
    2014-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144775
  • 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
    Epstein-barr virus, other - Product Code LSE
  • Reason
    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
  • Model / Serial
    Lot # 30804, Catalog # 720-600 Expiration Date April 30, 2015
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    Diamedix Is-EBV-VCA 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
  • Manufacturer Address
    Diamedix Corporation, 14100 Nw 57th Ct, Miami Lakes FL 33014-3107
  • Manufacturer Parent Company (2017)
    Diamedix, Inc.
  • Source
    USFDA