Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Binax

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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-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 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 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 and Original Applicant = BINAX, INC.
-
-