Class 3 Device Recall BD Shigella poly Group D Antiserum S. sonnei

• Date Initiated by Firm: January 25, 2010
• Date Posted: March 16, 2010
• Recall Status: Terminated on May 21, 2010
• Recall Number: Z-1149-2010
• Recall Event ID: 54374
• Product Classification: Antigens, all groups, shigella spp. - Product Code LIA
• Product: BD Shigella poly Group D Antiserum S. sonnei; types I,II, packaged in 3 mL vials, Catalog #24103, and labeled in part. Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA.; ; Used to confirm the identification of isolates that are morphologically and biochemically identified as Shigella species.
• Code Information: Lot Number: 8032036, exp 7/23/2010 and Lot Number: 9110319, exp 11/17/2011.
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; Sparks MD 21152-9212
• For Additional Information Contact: 410-316-4000
• Manufacturer Reason for Recall: In vitro diagnostic test reagent may exhibit decreased reactivity.
• FDA Determined Cause: Nonconforming Material/Component
• Action: BD Diagnostic Systems issued an "Urgent Product Recall" notification dated January 2010. Consignees were advised to discontinue use of the affected product and discard for replacement or credit. For further information, contact BD Diagnostic Systems, Customer Service at 1-800-675-0908.
• Quantity in Commerce: 1096 units
• Distribution: Nationwide Distribution
• 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.