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.
FDA Recall Z-1560-2008 · Posted 2008-08-08
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Recalling FirmBD Diagnostic Systems / Lee Laboratories
Recall StatusTerminated
Product CodeGTJ
Date Initiated2007-09-06
Date Terminated2009-03-24
Product Quantity540 units
Reason for Recall
Exhibits cross reactivity with Neisseria meningitides Group W135.
Firm 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Worldwide Distribution --- including USA and country of New Zealand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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