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Terminated

BD, Salmonella O Group A Antigen (1-2-12)

FDA Recall Z-0316-05 · Posted 2004-12-16

Recalling FirmBD Diagnostic Systems
Recall StatusTerminated
Product CodeGNC
Date Initiated2004-10-20
Date Terminated2005-02-01
Product Quantity130 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.

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