FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BD Shigella poly Group D Antiserum S. sonnei; types I,II, packaged in 3 mL vials, Catalog #24103, and labeled in part. Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA. Used to confirm the identification of isolates that are morphologically and biochemically identified as Shigella species.
- Recall number
- Z-1149-2010
- Recalling firm
- Becton Dickinson & Co.
- Product
- BD Shigella poly Group D Antiserum S. sonnei; types I,II, packaged in 3 mL vials, Catalog #24103, and labeled in part. Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA. Used to confirm the identification of isolates that are morphologically and biochemically identified as Shigella species.
- Status
- Terminated
- Initiated
- 2010-01-25
- Posted
- 2010-03-16
- Terminated
- 2010-05-21
- Reason
- In vitro diagnostic test reagent may exhibit decreased reactivity.
- Root cause
- Nonconforming Material/Component
- Action
- BD Diagnostic Systems issued an "Urgent Product Recall" notification dated January 2010. Consignees were advised to discontinue use of the affected product and discard for replacement or credit. For further information, contact BD Diagnostic Systems, Customer Service at 1-800-675-0908.
- Quantity
- 1096 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot Number: 8032036, exp 7/23/2010 and Lot Number: 9110319, exp 11/17/2011.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LIA
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- 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