| Class 3 Device Recall | |
Date Initiated by Firm | October 20, 2004 |
Date Posted | December 16, 2004 |
Recall Status1 |
Terminated 3 on February 01, 2005 |
Recall Number | Z-0319-05 |
Recall Event ID |
30443 |
Product Classification |
Antisera, Fluorescent, All Globulins, Proteus Spp. - Product Code GSY
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Product | BD, Proteus OX19 Antigen |
Code Information |
Catalogue #240782, Lot #3035884 |
Recalling Firm/ Manufacturer |
BD Diagnostic Systems 1475 Athens Hwy Grayson GA 30017-1538
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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 | 150 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 |
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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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