Recall Z-1561-2008
BD Diagnostic Systems / Lee Laboratories · initiated September 6, 2007
Product
BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 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 100 vial units For use in slide agglutination tests for serotyping Neisseria Meningitidis.
Codes / lots: Lot #6104713, EXP 2009-02-26
Reason for recall
Exhibits cross reactivity with Neisseria meningitides Group W135
FDA-determined cause: Mixed-up of materials/components
Action taken
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.
Details
- Recall number
- Z-1561-2008
- Initiated
- September 6, 2007
- Posted by FDA
- August 8, 2008
- Terminated
- March 24, 2009
- Product code
- GTJ – Antisera, All Groups, N. Meningitidis
- Quantity
- 200 units
- Distribution
- Worldwide Distribution --- including USA and country of New Zealand.
- Recalling firm
- BD Diagnostic Systems / Lee Laboratories, Grayson, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1559-2008 | BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which were…Exhibits cross reactivity with Neisseria meningitides Group W135. | 09/06/2007Terminated |
| Z-1560-2008 | BD DifcoTM Neisseria Meningitidis Antisera Group Y 228811, 1mL, in vials, which were…Exhibits cross reactivity with Neisseria meningitides Group W135. | 09/06/2007Terminated |
| Z-1562-2008 | BD DifcoTM Neisseria Meningitidis Antiserum Group Y 241113, 1mL, in vials, which were…Exhibits cross reactivity with Neisseria meningitides Group W135 | 09/06/2007Terminated |