BD, Salmonella O Group D Antigen (9-12) (Typhoid O)
FDA Recall Z-0312-05 · Posted 2004-12-16
Recalling FirmBD Diagnostic Systems
Recall StatusTerminated
Product CodeGNC
Date Initiated2004-10-20
Date Terminated2005-02-01
Product Quantity2,193 each vials (5ml per vial)
Reason for Recall
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Firm Action
Consignees were notified by letter beginning 10/20/2004.
Root Cause
Other
Distribution Pattern
Nationwide, Australia, Belgium, Canada, Chile, Ecuador, India, Korea, Malaysia, New Zealand, Singapore, Taiwan
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.