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U.S. Department of Health and Human Services

Class 3 Device Recall BD DifcoTM Neisseria Meningitidis Antiserum Group Y

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  Class 3 Device Recall BD DifcoTM Neisseria Meningitidis Antiserum Group Y see related information
Date Initiated by Firm September 06, 2007
Date Posted August 08, 2008
Recall Status1 Terminated 3 on March 24, 2009
Recall Number Z-1559-2008
Recall Event ID 46750
510(K)Number K844407  
Product Classification Meningitidis Antisera - Product Code GTJ
Product BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 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 1 vial units.

For use in slide agglutination tests for serotyping Neisseria Meningitidis.
Code Information Lot #6311396, EXP 2009-09-19 
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 500 units
Distribution Worldwide Distribution --- including USA and country of New Zealand.
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.
510(K) Database 510(K)s with Product Code = GTJ and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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