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
- Recall Number
- Z-1527-2008
- Event Number
- 46323
- Firm
- Becton Dickinson & Co.
- FEI Number
- 1119779
- Product Code
- GNB
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 30, 2007
- Posted
- August 16, 2008
- Terminated
- November 12, 2008
- Address
- 7 Loveton Cir, Sparks, MD, 21152-9212
Description
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.
In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.
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.
Worldwide Distribution
643 (recall total) vials