Recall Z-1149-2010 ยท LIA Antigens, All Groups, Shigella Spp.
Becton Dickinson & Co.
BD Shigella poly Group D Antiserum S. sonnei; types I,II, packaged in 3 mL vials, Catalog #24103, and labeled in part. Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA. Used to confirm the identification of isolates that are morphologically and biochemically identified as Shigella species.
| Date | Mar 16, 2010 (initiated Jan 25, 2010) |
| Status | Terminated |
| Reason | In vitro diagnostic test reagent may exhibit decreased reactivity. |
| Root cause | Nonconforming Material/Component |
| Action | BD Diagnostic Systems issued an "Urgent Product Recall" notification dated January 2010. Consignees were advised to discontinue use of the affected product and discard for replacement or credit. For further information, contact BD Diagnostic Systems, Customer Service at 1-800-675-0908. |
| Quantity | 1096 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.