Class 2 Device Recall Leica Biosystems Newcastle

• Date Initiated by Firm: December 30, 2015
• Date Posted: February 19, 2016
• Recall Status: Terminated on January 05, 2017
• Recall Number: Z-0823-2016
• Recall Event ID: 73095
• Product Classification: Immunohistochemistry reagents and kits - Product Code NJT
• Product: This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
• Code Information: Product Code/Name: PA0552 (All Lots) Bond Ready-to-Use Primary Antibody PAX-5 (1EW). Detection Kit: DS9800 BondTM Polymer Refine Detection Kit. Affected Detection Kit Lots: 42314, 42388, 42474, 42486, 42499, 42555, 42570, 42579, 42627, 42645, 42683, 42780, 42802, 42823, 42852, 43050.
• Recalling Firm/ Manufacturer: Leica Microsystems, Inc.; 1700 Leider Ln; Buffalo Grove IL 60089-6622
• For Additional Information Contact: Katya Mcgee; 847-405-5413
• Manufacturer Reason for Recall: The Bond" Polymer Refine Detection and Novolink" Polymer Detection System may not provide adequate staining when using a detection protocol where one of its components - Peroxide Block / Peroxidase Block is applied after the primary marker incubation as specified in the Instructions for Use Following the Instructions for Use.
• FDA Determined Cause: Component change control
• Action: The firm sent out a Medical Device Recall letter dated December 29th 2015 to two-hundred (200) consignees in the United States decribing the recall and the neccesary actions to be taken. These included: - Do not use or continue to use the listed antibody with the specified detection kits. - Order replacement detection kits for use with the listed antibody. - 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. -pass this notice primarily to the end users where the product has been sold and to all those within your organization who need to be aware of this issue. -Confirm reciept of the Recall Notice letter by signing and dating the attached Acknowledgement Form and faxing it back to us at 1-847-236-3747, or scan and email it to LMGRA@Leica-Microsystems.com Customer are requested to contact their local Leica representative if you have any questions or concerns, or alternatively please contact us at the following email address: Combination.Products@LeicaBiosystems.com Peter Lloyd Leica Biosystems Newcastle Ltd Balliol Business Park West Benton Lane Newcastle upon Tyne NE 12 8EW United Kingdom Telephone +44 191 215 0567 Facsimile: +44 191 215 1152
• Quantity in Commerce: 1700 units
• Distribution: US Consignees incluude: AR ,AZ ,CA ,CO ,CT ,DC ,DE ,FL ,GA ,HI ,IA ,IL ,KY ,LA ,MA ,MD ,MI ,MN ,MO ,MT ,NC ,NH ,NJ ,NY ,OH ,OK ,PA ,PR ,SC ,TN ,TX ,UT ,VA ,VT ,WA ,WI and WV. Foreign Consignees include:Argentina , Australia , Brazil , Bulgaria , Chile , China , Ecuador ,Egypt , El Salvador , Finland , France , Georgia , Germany , Greece , India , Italy , Japan , Jordan , Kuwait , Lebanon , Malaysia , Philippines , Poland , Portugal , Romania , Russian Fed. , Singapore , South Korea , Spain , Sweden , Switzerland , Thailand , Tunisia , Turkey , United Kingdom and United Arab Emirates.
• 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.