{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "124330", "product_res_number": "Z-0536-2014", "event_date_initiated": "0013-11-25", "event_date_posted": "2013-12-18", "recall_status": "Terminated", "event_date_terminated": "2014-09-04", "res_event_number": "66963", "product_code": "JJH", "product_description": "MagNA Pure 96 System\nVersion 1.0\nSoftware Version 2.0\n\nRobotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed MagNA Pure reagent kits, automated filling of different kinds of PCR reaction vessels.", "code_info": "Serial Numbers 2001, 2002, 2003, 2004, 2006, 2011, 2012, 2013, 2014, 2015, 2016, 2018, 2019, 2020, 2021, 2022, 2023, 2024, 2025, 2026, 2027, 2028, 4001, 4022, 4023, 4024, 4025.", "firm_fei_number": "1823260", "recalling_firm": "Roche Diagnostics Operations, Inc.", "address_1": "9115 Hague Rd", "city": "Indianapolis", "state": "IN", "postal_code": "46256-1025", "additional_info_contact": "Todd Siesky\n317-576-2000 Ext. 249", "reason_for_recall": "This issue is only relevant for customers importing xml files into the MagNA Pure 96 IVD instrument software for sample identification. There is a potential for sample mismatch when using the MagNA Pure 96 IVD instrument (catalog number 06541089001). Importing an order file in xml format to the MagNA Pure 96 IVD instrument software may result in a wrong sequence of samples in the graphical overvi", "root_cause_description": "Software design", "action": "Roche Diagnostics sent an URGENT Medical Device Correction Notice dated November 25, 2013, to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers.\n\nCustomers were advised to discontinue use of the Pipetting Report and to use the sample list file instead. The MagNA Pure 96 Instrument Operators Guide is being updated with an addendum addressing this issue.\n\n The letter included a Customer Response Form for customers to complete and return to the firm by FAX : 1-888-670-4135. Please contact the Roche Support Network Customer Support Center at 1-800-526-1247, 24 hours a day, seven days a week, if you have questions about the information contained in this UMDC.", "product_quantity": "27", "distribution_pattern": "US Distribution including the states of AL, AZ, CA, CT, GA, NY, NC, NJ, OH, TX, VA and WA.", "openfda": { "k_number": [ "K113731", "K960298", "K770398", "K870690", "K943965", "K943966", "K871290", "K760592", "K851393", "K941326", "K801772", "K893733", "K833919", "K935496", "K930168" ], "registration_number": [ "3008937712", "3021043070", "3016837106", "3028944399", "3016619649", "3010031137", "3009238284", "3013540184", "9610126", "3020831613", "3006786907", "2134567", "3017434950", "3012259842", "3015542780", "3005248192", "3009875001", "3017583200", "3016998616", "3003402518", "3005118020", "1119779", "3009207631", "3009311010", "3016763307", "3013096769", "2030633", "3015980628", "8043379", "3021269066", "3009155756", "3003795116", "9610529", "3007420875", "2915796", "3016733849", "3010030414", "3028240331", "3004141078", "3004013603", "3017098905", "3007287152", "3026035655", "3019837962", "3005695808", "3016764493", "3010594620", "3009214950", "3012494290", "3011781554", "3009443851", "3014100717", "3009573214", "3017170972", "3013548521", "3010791816", "3007808978", "3006198300", "1650733", "3012101172", "8020892", "3005748564", "3007143373", "3002777243", "3005271071", "3004530258", "3014325803", "3013756523", "3004417597", "3003335080", "3024647994", "3018771894", "3016068451", "3003083993", "2025606", "8030996", "3018779125", "3007054022", "1224838", "3027518847", "2024800", "3015529000", "3016635427", "3017358793", "1550222", "9615754", "3038622676", "3002821232", "3045058049", "3016611336", "3013496958", "3008517993", "3014290238", "8043909", "3007699074", "3016764932", "9615037", "3020925311", "3003673482", "9612003" ], "fei_number": [ "3008937712", "3021043070", "3016837106", "3028944399", "3016619649", "3010031137", "3000210620", "3009238284", "3013540184", "3020831613", "3006786907", "3017434950", "3012259842", "3015542780", "3005248192", "3009875001", "3017583200", "3016998616", "3003402518", "1119779", "3009207631", "3009311010", "3016763307", "3013096769", "3015980628", "3003413192", "3021269066", "3009155756", "3003795116", "1000513605", "3007420875", "2915796", "3002806560", "3016733849", "3010030414", "3028240331", "3004141078", "3004013603", "3017098905", "3003261083", "3007287152", "3026035655", "3019837962", "3005695808", "3016764493", "3010594620", "3009214950", "3012494290", "3002808498", "3011781554", "3009443851", "3014100717", "3009573214", "3017170972", "3013548521", "3010791816", "3007808978", "3006198300", "3005748564", "3007143373", "3002777243", "3005271071", "3004530258", "3014325803", "3013756523", "3002622561", "3004417597", "3003335080", "3024647994", "3018771894", "3016068451", "3003083993", "2025606", "3002524000", "3018779125", "3009391812", "3007054022", "3027518847", "3001421318", "2024800", "3015529000", "3016635427", "3017358793", "1000532580", "3002807666", "1318994", "3002806559", "1550222", "3008237827", "3038622676", "3002821232", "3045058049", "3016611336", "3013496958", "3008517993", "3014290238", "3007699074", "3016764932", "3020925311", "3003673482" ], "device_name": "Clinical Sample Concentrator", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2310", "device_class": "1" } } ] }