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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 Ysee related information
Date Initiated by FirmSeptember 06, 2007
Date PostedAugust 08, 2008
Recall Status1 Terminated 3 on March 24, 2009
Recall NumberZ-1560-2008
Recall Event ID 46750
510(K)NumberK844407 
Product Classification Meningitidis Antisera - Product Code GTJ
ProductBD 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 #6250885, EXP 2009-02-26 
Recalling Firm/
Manufacturer		 BD Diagnostic Systems / Lee Laboratories
1475 Athens Hwy
Grayson GA 30017-1538
For Additional Information ContactMr. 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
ActionBD 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 Commerce540 units
DistributionWorldwide Distribution --- including USA and country of New Zealand.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GTJ
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