Atlas FDA

NOW Filariasis Rapid test for W. bancrofti antigen. (Export use only) Item Number 620-430, Kit Number 620-000,

FDA device recall Z-0779-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm
Binax, Inc.
Reason for recall
Pouch integrity compromised
Action taken
Binax initiated the recall on 2/18/04 by telephone or email to customers. European customers were notiified by letter.
Root cause
Other
Status
Terminated
Product code
NES
Quantity affected
353 kits
Distribution
KS International: Australia, New Zealand, Japan,Sri-Lanka France, The Netherlands, U.A.E., Oman, S. Africa, Hong Kong, Zimbabwe, India
Date initiated
2004-02-18
Date posted
2004-07-20
Date terminated
2004-08-09
Location
Portland, ME

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