Events

Recall of Device Recall IgG Conjugate

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

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
    64164
  • Event Risk Class
    Class 3
  • Event Number
    Z-1477-2013
  • Event Initiated Date
    2013-01-23
  • Event Date Posted
    2013-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115471
  • 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
    Antisera, cf, herpesvirus hominis 1,2 - Product Code GQO
  • Reason
    Affected products have a labeled expiration date of one year too long.
  • Action
    MBL Bion sent an Urgent Product Recall letter dated January 28, 2013 to all affected customers via email. The letter identified the affected product, problem and actions to be taken. Customers were requested to destroy the affected product and to notify Bion of the number of units consumed and destroyed. For questions call 847-544-5044.

Device

Device Recall IgG Conjugate
  • Model / Serial
    Product Code: CCG-9912;   Lot: CCG-0280
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)
  • Product Description
    Plastic bottle containing 10.5 mL of IgG Conjugate || Product Usage: || Product is a used as a counterstain for various indirect fluorescent assay kits
  • Manufacturer
    Bion Enterprises Ltd

Manufacturer

Bion Enterprises Ltd
  • Manufacturer Address
    Bion Enterprises Ltd, 455 State St, Suite 100, Des Plaines IL 60016-2204
  • Manufacturer Parent Company (2017)
    JSR Corp.
  • Source
    USFDA