Class 2 Device Recall Novocastra Liquid Mouse Monoclonal Antibody Calretinin

• Date Initiated by Firm: March 22, 2016
• Create Date: May 21, 2016
• Recall Status: Terminated on November 30, 2017
• Recall Number: Z-1704-2016
• Recall Event ID: 73823
• Product Classification: Immunohistochemistry reagents and kits - Product Code NJT
• Product: Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
• Code Information: Lot numbers: 6025204, 6029060, 6029949, 6035923 and 6036060.
• Recalling Firm/ Manufacturer: Leica Microsystems, Inc.; 1700 Leider Ln; Buffalo Grove IL 60089-6622
• For Additional Information Contact: Katya Magee; 847-405-5413
• Manufacturer Reason for Recall: Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining.
• FDA Determined Cause: Nonconforming Material/Component
• Action: A Medical Device Recall Notification letter was sent via e-mail on April 5, 2015 to the consignees describing the nature of the recall and action that needed to be taken. The firm requested that the consignees take the following actions: Only use Novocastra Liquid Mouse Monoclonal Antibody Calretinin with the lot numbers of diluent specified. There is no need for retrospective review of tissue staining if appropriate positive controls were properly used and interpreted during the immuno / in situ staining. Complete and return the attached acknowledgment. The firm requests that consignees contact their local Leica representative if they have any questions or concerns, or alternatively please contact the firm at the following e-mail address; LMGRA@leica-microsystems.com
• Quantity in Commerce: 290 units
• Distribution: Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of 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.