Z-0268-05

BD Phoenix ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600, and 448708...

Name: Z-0268-05 BD Phoenix ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600, and 448708...
Creator: Becton Dickinson & Co.
Published: 2004-10-29
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2004-10-29 / Terminated / root cause: packaging

FDA source

Becton Dickinson & Co. began a recall of BD Phoenix ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600, and 448708, packaged in cartons of 25 panels on 2004-10-29. The reason FDA records is "The foil pouch containing an in vitro diagnostic test kit for bacteria identification in patient samples may be defective and cause incorrect patient results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0268-05
Status: Terminated
Initiated: 2004-10-29
Posted: 2004-11-30
Terminated: 2005-01-31
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.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: 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 tag: packaging
FDA 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.
Distribution: Product was sold to direct accounts nationwide and to the firm''s affiliate distributors worldwide.
Product codes and lots: 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

Product code LON

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)