BD, Francisella tularensis Antigen
FDA device recall Z-0320-05 · posted 2004-12-16 · Terminated
Recall details
- Recalling firm
- BD Diagnostic Systems
- 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.
- Action taken
- Consignees were notified by letter beginning 10/20/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- GSK
- Quantity affected
- 1329 vials (5ml per vial)
- Distribution
- Nationwide, Australia, Belgium, Canada, Chile, Ecuador, India, Korea, Malaysia, New Zealand, Singapore, Taiwan
- Date initiated
- 2004-10-20
- Date posted
- 2004-12-16
- Date terminated
- 2005-02-01
- Location
- Grayson, GA
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