| | 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-0321-05 |
|---|
| Recall Event ID |
30443 |
| Product Classification |
Antisera, Fluorescent, All Globulins, Proteus Spp. - Product Code GSY
|
| Product | BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19) |
|---|
| Code Information |
Catalogue #240490, Lot #3079439 |
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 | 100 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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