Recall Z-1527-2008 ยท GNB Antisera, All Types, Shigella Spp.
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.
| Date | Aug 16, 2008 (initiated Nov 30, 2007) |
| Status | Terminated |
| Reason | In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 643 (recall total) vials |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.