Class 3 Device Recall Difco Salmonella 0 Group A Antigen, catalog 240731,

• Date Initiated by Firm: May 19, 2010
• Date Posted: July 15, 2010
• Recall Status: Terminated on July 21, 2010
• Recall Number: Z-2025-2010
• Recall Event ID: 55867
• Product Classification: Antigens, febrile, slide and tube, all groups, salmonella spp - Product Code GNC
• Product: Difco Salmonella 0 Group A Antigen, catalog #240731, packaged in 5 mL glass vials, labeled in part ***Becton, Dickinson and Company, Sparks, MD 21152***
• Code Information: Lot 9126057, Exp May 04, 2012
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; BD Diagnostic Systems; 7 Loveton Circle; Sparks MD 21152-0999
• For Additional Information Contact: Kim Cartier; 410-316-4000
• Manufacturer Reason for Recall: In vitro diagnostic reagent to aid in the diagnosis of Salmonellosis may exhibit decreased or no reactivity. If proper controls are run with the lot in question, it would become apparent that the antigen is non reactive and patient specimen results should not be reported. If control testing is not performed a salmonella-infected patient could go undiagnosed, with possible adverse effects.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The recalling firm notified customers by fax and e-mail on 05/19/10. The notification advised that the referenced lot number of Salmonella 0 Group A Antigen may exhibit decreased or no reactivity when testing the patient's serum directly for homologous antibodies by either a slide or tube agglutination test to aid in the diagnosis of Salmonellosis. The recalling firm also advised that they would issue replacements for the referenced lot number under Catalog number 240731, which would not be available until approximately July 15, 2010. Consignees were requested to return enclosed response form. Customers with questions about replacements should contact BD customer service at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.
• Quantity in Commerce: 93 units
• Distribution: Product was sold to distributors nationwide and to affiliates in Belgium and Korea.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.