Class 2 Device Recall Leica Microsystems Inc

• Date Initiated by Firm: November 27, 2015
• Date Posted: February 12, 2016
• Recall Status: Terminated on January 05, 2017
• Recall Number: Z-0808-2016
• Recall Event ID: 72802
• Product Classification: Immunohistochemistry reagents and kits - Product Code NJT
• Product: Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
• Code Information: Product Code DS9390 with lot numbers 41203, 41407, 41478, 41575, 41619, 41779, 41872, 42027, 42105, 42172, 42181, 42251, 42345, 42397, 42512 and 42594.
• 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: The Firm informed the importer/distributor, Leica Microsystems, a manufacturing error occurred during the filling of some containers of the Bond Polymer Refine Red Detection DS9390 kits, which may result in inadequate staining.
• FDA Determined Cause: Mixed-up of materials/components
• Action: Leica Biosystems sent an Urgent Medical Device Recall Notice dated November 30, 2015, to all affected customer. The letter identified the product the problem and the action needed to be taken by the customer. 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. Please also properly destroy any unused or partially used affected lots of the reagent, and indicate by signing and returning the attached Medical Device Recall Acknowledgement Form that this action has been undertaken. As indicated in the Instructions for Use, the clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist. The consignees are requested to consult with their laboratory director and physician to determine whether a review of past results obtained from the affected lots is clinically warranted. Direct accounts are requested to forward the notice primarily to the end users where the product has been sold and to all those within the organization who need to be aware of this issue. Periodic effectiveness checks will be conducted to address non responders. For further questions please call ( 847) 405-5413
• Quantity in Commerce: 3745
• Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Argentina, Australia, Austria, Belgium, Chile, Denmark, France, Germany, Greece, Hong Kong, Italy, Japan , Netherlands, Romania Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and UK.
• 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.