Class 2 Device Recall Binax

• Date Initiated by Firm: February 18, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on August 09, 2004
• Recall Number: Z-0778-04
• Recall Event ID: 28457
• 510(K)Number: K032166
• Product Classification: Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus - Product Code GQG
• Product: NOW RSV Test Item Number 430-430, Kit Number 430-00R
• Code Information: Lot # 015168 and 015172
• Recalling Firm/ Manufacturer: Binax, Inc.; 217 Read St; Portland ME 04103-3460
• Manufacturer Reason for Recall: Pouch integrity compromised
• FDA Determined Cause: 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: 667 kits
• Distribution: KS International: Australia, New Zealand, Japan,Sri-Lanka France, The Netherlands, U.A.E., Oman, S. Africa, Hong Kong, Zimbabwe, India
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = GQG