FDA Medical Device Recalls (openFDA)
BD Diagnostic Systems / Lee Laboratories: DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic.
- Recall number
- Z-1319-2008
- Recalling firm
- BD Diagnostic Systems / Lee Laboratories
- Product
- DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic.
- Status
- Terminated
- Initiated
- 2007-08-08
- Posted
- 2008-09-11
- Terminated
- 2009-03-24
- Reason
- Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism.
- Root cause
- Nonconforming Material/Component
- Action
- Becton Dickinson (BD) Diagnostic Systems sent an Urgent product recall letter, dated August 2007, to all consignees, directing them to discard this lot of product. BD instructed distributors to discontinue distribution and discard any remaining product in inventory. BD requested the distributors provide an Excel file or a customer list containing the name, address and telephone number of end-users who were shipped the product. BD provided alternative testing methods. A response form was included to verify receipt of notification.
- Quantity
- 26 units
- Distribution
- Nationwide Distribution and Canada
- Lot, serial or model codes
- Catalog number: 223181, Lot number: 6122656, Exp: 20090705.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GTQ
- 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