Class 2 Device Recall LEICA BIOSYSTEMS NEWCASTLE LTD

• Date Initiated by Firm: April 05, 2016
• Create Date: June 01, 2016
• Recall Status: Terminated on November 30, 2017
• Recall Number: Z-1877-2016
• Recall Event ID: 73802
• Product Classification: Immunohistochemistry reagents and kits - Product Code NJT
• Product: Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
• Code Information: 1ml size Novocastr Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) with lot numbers 6032734, 6033766, 6037153 and 6039088.
• Recalling Firm/ Manufacturer: Leica Microsystems, Inc.; 1700 Leider Ln; Buffalo Grove IL 60089-6622
• For Additional Information Contact: Katya Magee; 800-225-8867
• Manufacturer Reason for Recall: Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling.
• FDA Determined Cause: Nonconforming Material/Component
• Action: An Urgent: Medical Device Recall Notification dated 4/5/2016 was sent to consignees with the affected lots of CDX2 and RCC marker. The customers were notified of the problems as well as the following actions to be taken by the consignees: Do not use or continue to use the reagent lots listed above, as they have the potential to result in inadequate tissue staining and lead to weak or false negative pathology results. Appropriately destroy any unused or partially used affected lots of the reagent Complete the attached Recall Notification Acknowledgement Form that this action has been undertaken. The firm also request that the notification is passed to all those within their organization who need to be aware of this issue. The firm requests consignees to return the completed acknowledgement form to LMGRA@Leica-Microsystems.com to receive credit for affected lots that have been destroyed by the consignees laboratory.
• Quantity in Commerce: 90 Units
• Distribution: Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
• 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.