Recall Z-0318-05 ยท GSN Antiserum, Positive And Negative Febrile Antigen Control Serum
BD Diagnostic Systems
BD, Salmonella Flagellar Polyvalent Antiserum (a,b,d)
| Date | Dec 16, 2004 (initiated Oct 20, 2004) |
| Status | Terminated |
| Reason | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. |
| Root cause | Other |
| Action | Consignees were notified by letter beginning 10/20/2004. |
| Quantity | 40 vials (5ml per vial) |
| Distribution | Nationwide, Australia, Belgium, Canada, Chile, Ecuador, India, Korea, Malaysia, New Zealand, Singapore, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.