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U.S. Department of Health and Human Services

Class 2 Device Recall Binax

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  Class 2 Device Recall Binax see related information
Date Initiated by Firm February 18, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on August 09, 2004
Recall Number Z-0780-04
Recall Event ID 28457
Product Classification unknown device name - Product Code NED
Product NOW Malaria (Export use only)
Item Number 660-430, Kit Number 66005,
Kit Number 660-000
Code Information Lot Number 015001, 015002
Recalling Firm/
Binax, Inc.
217 Read St
Portland ME 04103-3460
Manufacturer Reason
for Recall
Pouch integrity compromised
FDA Determined
Cause 2
Action Binax initiated the recall on 2/18/04 by telephone or email to customers. European customers were notiified by letter.
Quantity in Commerce 555 kits
Distribution KS International: Australia, New Zealand, Japan,Sri-Lanka France, The Netherlands, U.A.E., Oman, S. Africa, Hong Kong, Zimbabwe, India

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.