{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "143048", "product_res_number": "Z-0823-2016", "event_date_initiated": "2015-12-30", "event_date_posted": "2016-02-19", "recall_status": "Terminated", "event_date_terminated": "2017-01-05", "res_event_number": "73095", "product_code": "NJT", "product_description": "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_info": "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.", "firm_fei_number": "3000210133", "recalling_firm": "Leica Microsystems, Inc.", "address_1": "1700 Leider Ln", "city": "Buffalo Grove", "state": "IL", "postal_code": "60089-6622", "additional_info_contact": "Katya Mcgee\n847-405-5413", "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.", "root_cause_description": "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: \n \n- Do not use or continue to use the listed antibody with the specified detection kits.\n- Order replacement detection kits for use with the listed antibody.\n- 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. \n-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.\n-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 \n\nCustomer 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: \n\nCombination.Products@LeicaBiosystems.com\n\nPeter Lloyd\nLeica Biosystems Newcastle Ltd\nBalliol Business Park West\nBenton Lane\nNewcastle upon Tyne NE 12 8EW\nUnited Kingdom\nTelephone +44 191 215 0567\nFacsimile: +44 191 215 1152", "product_quantity": "1700 units", "distribution_pattern": "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.", "openfda": { "registration_number": [ "2083544", "3015258926", "2914537", "9610099", "3010939897", "3008776165", "3014429566", "1640981", "3016764932", "3003423869", "1831638", "3013059683", "8020030", "3014165737", "3004859032", "2028492", "3042159574", "3008773547", "9610126", "3009963993", "1649339", "3017170972", "3005592623", "3027582128", "3003741796", "3007035884", "3015614371", "3004074729", "3017439370", "3008505743", "3004140393", "3030509363", "3008174888", "3013043616", "3009189893", "2916205", "3017379203", "3003335080", "3012214605", "9610529", "2022180", "3017212430", "3010139432", "3042585783", "3010890428" ], "fei_number": [ "2083544", "3000718726", "3015258926", "2914537", "3002806559", "3010939897", "3014429566", "1640981", "3016764932", "3003423869", "1831638", "3013059683", "3014165737", "3004859032", "3042159574", "3008773547", "3002806560", "3009963993", "3017170972", "3005592623", "3027582128", "3003741796", "2936532", "3007035884", "3015614371", "3004074729", "3017439370", "3008505743", "3004140393", "3030509363", "3008174888", "3002806778", "1000125183", "3013043616", "3009189893", "2916205", "3017379203", "3003335080", "3012214605", "2022180", "3017212430", "3006461677", "3010139432", "3042585783", "3010890428" ], "device_name": "Immunohistochemistry Reagents And Kits", "medical_specialty_description": "Hematology", "regulation_number": "864.1860", "device_class": "1" } } ] }