Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0268-05 · Posted 2004-11-30

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeLON
Date Initiated2004-10-29
Date Terminated2005-01-31

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑