—#35890

Product

BD Phoenix ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600, and 448708, packaged in cartons of 25 panels.

FDA product code: LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: Product was sold to direct accounts nationwide and to the firm''s affiliate distributors worldwide.

Timeline

Recall initiated: 2004-10-29
Posted by FDA: 2004-11-30
Terminated: 2005-01-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #35890. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.