Events

Recall of Device Recall Binax

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

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
    28457
  • Event Risk Class
    Class 2
  • Event Number
    Z-0780-04
  • Event Initiated Date
    2004-02-18
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31931
  • 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
    unknown device name - Product Code NED
  • Reason
    Pouch integrity compromised.
  • Action
    Binax initiated the recall on 2/18/04 by telephone or email to customers. European customers were notiified by letter.

Device

Device Recall Binax
  • Model / Serial
    Lot Number 015001, 015002
  • Distribution
    KS International: Australia, New Zealand, Japan,Sri-Lanka France, The Netherlands, U.A.E., Oman, S. Africa, Hong Kong, Zimbabwe, India
  • Product Description
    NOW Malaria (Export use only) || Item Number 660-430, Kit Number 66005, || Kit Number 660-000
  • Manufacturer
    Binax, Inc.

Manufacturer

Binax, Inc.
  • Manufacturer Address
    Binax, Inc., 217 Read St, Portland ME 04103-3460
  • Source
    USFDA