Z-0312-05
BD, Salmonella O Group D Antigen (9-12) (Typhoid O)
Lee Laboratories, Inc. / initiated 2004-10-20 / Terminated
BD Diagnostic Systems began a recall of BD, Salmonella O Group D Antigen (9-12) (Typhoid O) on . The reason FDA records is "Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0312-05
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Lee Laboratories, Inc.
- Product
- BD, Salmonella O Group D Antigen (9-12) (Typhoid O)
- Product code
- GNC Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
- 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.
- FDA root cause
- Other
- Action
- Consignees were notified by letter beginning 10/20/2004.
- Quantity in commerce
- 2,193 each vials (5ml per vial)
- Distribution
- Nationwide, Australia, Belgium, Canada, Chile, Ecuador, India, Korea, Malaysia, New Zealand, Singapore, Taiwan
- Product codes and lots
- Catalogue #24074, Lot #2119981
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