BD Phoenix ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600, and 448708, packaged in carton
FDA device recall Z-0268-05 · posted 2004-11-30 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LON
- Distribution
- Product was sold to direct accounts nationwide and to the firm''s affiliate distributors worldwide.
- Date initiated
- 2004-10-29
- Date posted
- 2004-11-30
- Date terminated
- 2005-01-31
- Location
- Sparks, MD
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