Date Initiated by Firm | September 06, 2007 |
Date Posted | August 08, 2008 |
Recall Status1 |
Terminated 3 on March 24, 2009 |
Recall Number | Z-1561-2008 |
Recall Event ID |
46750 |
510(K)Number | K844407 |
Product Classification |
Meningitidis Antisera - Product Code GTJ
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Product | BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 100 vial units
For use in slide agglutination tests for serotyping Neisseria Meningitidis. |
Code Information |
Lot #6104713, EXP 2009-02-26 |
Recalling Firm/ Manufacturer |
BD Diagnostic Systems / Lee Laboratories 1475 Athens Hwy Grayson GA 30017-1538
|
For Additional Information Contact | Mr. Steve J. Strouphauer 770-972-4450 |
Manufacturer Reason for Recall | Exhibits cross reactivity with Neisseria meningitides Group W135 |
FDA Determined Cause 2 | Mixed-up of materials/components |
Action | BD Diagnostics sent an Urgent Product Recall letter, dated September 2007, to all accounts, requesting the discontinue of distribution and that any remaining inventory of the recalled product be discarded. BD will issue credit or send replacement. A receipt of notification needs to be completed and sent back whether or not customers have any remaining inventory. Also, a customer list of end-users who were shipped this product needs to be provided so that the firm may inform them of the issue. |
Quantity in Commerce | 200 units |
Distribution | Worldwide Distribution --- including USA and country of New Zealand. |
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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510(K) Database | 510(K)s with Product Code = GTJ
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