FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BD Phoenix ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600, and 448708, packaged in cartons of 25 panels.
- Recall number
- Z-0268-05
- Recalling firm
- Becton Dickinson & Co.
- Product
- BD Phoenix ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600, and 448708, packaged in cartons of 25 panels.
- Status
- Terminated
- Initiated
- 2004-10-29
- Posted
- 2004-11-30
- Terminated
- 2005-01-31
- Reason
- The foil pouch containing an in vitro diagnostic test kit for bacteria identification in patient samples may be defective and cause incorrect patient results.
- Root cause
- Other
- Action
- BD Diagnostic Systems notified end users by letter dated October 2004. The firm''s sales representatives delivered the letters initially on 10/29/04. The letter advises end users to examine identified lots for defects using a diagram provided with the notification and discard any suspect product for replacement. A response form is included with the notification.
- Quantity
- not on file
- Distribution
- Product was sold to direct accounts nationwide and to the firm''s affiliate distributors worldwide.
- Lot, serial or model codes
- Lots: 3316699 11/30/2004 4146868 05/31/2005 4063959 03/31/2005 4231466 08/31/2005 3288384 10/31/2004 3316697 11/30/2004 4035990 02/28/2005 4063276 03/31/2005 4133618 05/31/2005 4203249 07/31/2005 4209161 08/31/2005 4245919 09/30/2005 4231472 08/31/2005 4181008 07/31/2005 4224731 08/31/2005 4231473 08/31/2005 4224708 08/31/2005
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LON
- 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