FDA Medical Device Recalls (openFDA)
BD Diagnostic Systems / Lee Laboratories: BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton Dickinson and Company, Sparks, MD 21152. The product is packaged in 1 vial units. For use in slide agglutination tests for serotyping Neisseria Meningitidis.
- Recall number
- Z-1559-2008
- Recalling firm
- BD Diagnostic Systems / Lee Laboratories
- Product
- BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton Dickinson and Company, Sparks, MD 21152. The product is packaged in 1 vial units. For use in slide agglutination tests for serotyping Neisseria Meningitidis.
- Status
- Terminated
- Initiated
- 2007-09-06
- Posted
- 2008-08-08
- Terminated
- 2009-03-24
- Reason
- Exhibits cross reactivity with Neisseria meningitides Group W135.
- Root cause
- Mixed-up of materials/components
- Action
- BD Diagnostics sent an Urgent Product Recall letter, dated September 2007, to all accounts, requesting the discontinue of distribution and that any remaining inventory of the recalled product be discarded. BD will issue credit or send replacement. A receipt of notification needs to be completed and sent back whether or not customers have any remaining inventory. Also, a customer list of end-users who were shipped this product needs to be provided so that the firm may inform them of the issue.
- Quantity
- 500 units
- Distribution
- Worldwide Distribution --- including USA and country of New Zealand.
- Lot, serial or model codes
- Lot #6311396, EXP 2009-09-19
- 510(k) numbers
- ["K844407"]
- PMA numbers
- not on file
- Product code
- GTJ
- 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