Difco(tm) Shigella Antiserum Poly Group B, Catalog # 228351, in 3 mL vials individually sold or packed as a component in the Difco(tm) "Shigella Grouping Antiserum Set", Cat. 241108, Lot 6073806). Vials are labeled in part ***S. flexneri Serotypes 1-6***Becton, Dickinson and Company Sparks, MD 21152*** Used for the identification of Shigella species by the slide agglutination test.
FDA Recall Z-1527-2008 · Posted 2008-08-16
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Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeGNB
Date Initiated2007-11-30
Date Terminated2008-11-12
Product Quantity643 (recall total) vials
Reason for Recall
In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.
Firm Action
The recalling firm notified distributors by faxed letter flagged as "Urgent Product Recall" and e-mail on 11/30/07. Distributors were instructed to cease distribution and discard identified product and return a list of end user consignees for direct notification by Becton Dickinson. End users were notified by letter flagged as an "Urgent Product Recall" on 11/30/06 through 12/06/07. Customers were instructed to discontinue and discard affected product for replacement. The notification included a reply form that BD requested users to fax back with the quantity of replacement vials needed.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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