| Class 2 Device Recall Binax |  |
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
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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/ Manufacturer |
Binax, Inc. 217 Read St Portland ME 04103-3460
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Manufacturer Reason for Recall | Pouch integrity compromised |
FDA Determined Cause 2 | Other |
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
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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.
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