Recall Z-1560-2008 ยท GTJ Antisera, All Groups, N. Meningitidis
BD Diagnostic Systems / Lee Laboratories
BD DifcoTM Neisseria Meningitidis Antisera Group Y 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 1 vial units. For use in slide agglutination tests for serotyping Neisseria Meningitidis.
| Date | Aug 8, 2008 (initiated Sep 6, 2007) |
| Status | Terminated |
| Reason | Exhibits cross reactivity with Neisseria meningitides Group W135. |
| Root cause | Mixed-up of materials/components |
| Action | BD Diagnostics sent an Urgent Product Recall letter, dated September 2007, to all accounts, requesting the discontinue of distribution and that any remaining inventory of the recalled product be discarded. BD will issue credit or send replacement. A receipt of notification needs to be completed and sent back whether or not customers have any remaining inventory. Also, a customer list of end-users who were shipped this product needs to be provided so that the firm may inform them of the issue. |
| Quantity | 540 units |
| Distribution | Worldwide Distribution --- including USA and country of New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K844407 | DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST Bd Becton Dickinson Vacutainer Systems Preanalytic, Jan 25, 1985 |