FDA Medical Device Recalls (openFDA)
BD Diagnostic Systems: BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19)
- Recall number
- Z-0321-05
- Recalling firm
- BD Diagnostic Systems
- Product
- BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19)
- Status
- Terminated
- Initiated
- 2004-10-20
- Posted
- 2004-12-16
- Terminated
- 2005-02-01
- 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
- 100 vials (5ml per vial)
- Distribution
- Nationwide, Australia, Belgium, Canada, Chile, Ecuador, India, Korea, Malaysia, New Zealand, Singapore, Taiwan
- Lot, serial or model codes
- Catalogue #240490, Lot #3079439
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GSY
- Firm FEI
- 1025402
- Firm city
- Grayson
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28