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U.S. Department of Health and Human Services

Class 3 Device Recall

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  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-0314-05
Recall Event ID 30443
Product Classification Antigens (Febrile), Agglutination, Brucella Spp. - Product Code GSO
Product BD, Brucella abortus Antigen
Code Information Catalogue #241049, Lot #2192837, 3029141, 2116596, 3029124 & 2092005
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 1859 vials (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.
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