Becton Dickinson & Co. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Becton Dickinson & Co.
Lot Codes / Batch Numbers
Lot 5059542 Exp March 30, 2008 Lot 6023471 Exp March 30, 2008 Lot 7072998 Exp March 30, 2008 Lot 7116967 Exp April 12, 2010
Products Sold
Lot 5059542 Exp March 30, 2008 Lot 6023471 Exp March 30, 2008 Lot 7072998 Exp March 30, 2008 Lot 7116967 Exp April 12, 2010
Becton Dickinson & Co. is recalling Difco(tm) Shigella Antiserum Poly Group B, Catalog # 228351, in 3 mL vials individually sold or pack due to In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026