• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall

  • 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 3 Device Recall see related information
Date Initiated by Firm October 20, 2004
Date Posted December 16, 2004
Recall Status1 Terminated 3 on February 01, 2005
Recall Number Z-0315-05
Recall Event ID 30443
Product Classification Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. - Product Code GNC
Product BD, Salmonella Flagellar d Antigen (Typhoid H)
Code Information Catalogue #240785, Lot #2192844 & Lot # 2270533
Recalling Firm/
Manufacturer
BD Diagnostic Systems
1475 Athens Hwy
Grayson GA 30017-1538
For Additional Information Contact Gail M. Claiborne
410-316-4054
Manufacturer Reason
for Recall
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
FDA Determined
Cause 2
Other
Action Consignees were notified by letter beginning 10/20/2004.
Quantity in Commerce 625 vials F(5ml per vial)
Distribution Nationwide, Australia, Belgium, Canada, Chile, Ecuador, India, Korea, Malaysia, New Zealand, Singapore, Taiwan
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.
-
-