{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "104467", "product_res_number": "Z-0365-2012", "event_date_initiated": "2011-10-11", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2016-02-23", "res_event_number": "60117", "product_code": "JJH", "k_numbers": [ "K092705" ], "product_description": "Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14", "code_info": "list 09K14, all serial numbers", "firm_fei_number": "3005248192", "recalling_firm": "Abbott Molecular", "address_1": "1300 E Touhy Ave", "city": "Des Plaines", "state": "IL", "postal_code": "60018-3315", "additional_info_contact": "224-361-7133", "reason_for_recall": "Abbott Molecular has received reports in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated and/or caught fire.", "root_cause_description": "Component design/selection", "action": "Abbott Molecular sent a Field Correction Recall letter dated October 10, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The customer was instructed to follow the instructions identified until further notice, and to complete the enclosed reply sheet and fax it to (847) 775-6728 at their earliest convenience to acknowledge receipt and understanding of the letter.\n\nFor questions regarding this recall call 224-361-7133.", "product_quantity": "432 units", "distribution_pattern": "Worldwide Distribution -- USA (nationwide) including the countries of Algeria, Australia, Austria, Azerbaijan, Belgium, Brazil, Burundi, Cameroon, China, Croatia, Estonia, Ethiopia, Finland, France, Gaza & Jericho, Germany, India, Ireland, Israel, Italy, Kazakhstan, Kenya, Libya, Malawi, Malaysia, Mali, Mozambique, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, Uganda, Ukraine, United Kingdom, Vietnam and Zambia", "openfda": { "k_number": [ "K941326", "K801772", "K770398", "K851393", "K943966", "K943965", "K930168", "K960298", "K113731", "K893733", "K760592", "K935496", "K833919", "K871290", "K870690" ], "registration_number": [ "3024647994", "3008517993", "3005271071", "3012494290", "3020925311", "3009155756", "2134567", "3019837962", "3002777243", "2915796", "3005118020", "3015529000", "3016837106", "3017170972", "1650733", "3016611336", "3004530258", "3017098905", "3012101172", "8020892", "3010594620", "3018771894", "3003083993", "3009443851", "3009207631", "3011781554", "9615754", "3021269066", "3009238284", "3005695808", "3016764932", "3016763307", "3013540184", "3028944399", "9610126", "3015542780", "3005748564", "3007420875", "3027518847", "2025606", "3004141078", "3006198300", "3013756523", "3013548521", "3004417597", "3007808978", "3010791816", "3016733849", "3010030414", "3017434950", "3009214950", "3020831613", "3009573214", "3007143373", "9615037", "3009875001", "8030996", "3003795116", "3010031137", "3045058049", "3008937712", "3012259842", "1119779", "3003402518", "3007287152", "3013496958", "3017583200", "1550222", "3038622676", "3021043070", "3016619649", "9612003", "3028240331", "3015980628", "3014325803", "3005248192", "3004013603", "8043379", "2024800", "3002821232", "3016764493", "3006786907", "3007054022", "3017358793", "3014290238", "3009311010", "3016998616", "3003673482", "3003335080", "8043909", "3018779125", "3026035655", "3016068451", "2030633", "3013096769", "3016635427", "1224838", "3007699074", "9610529", "3014100717" ], "fei_number": [ "3024647994", "3008517993", "3005271071", "3012494290", "3020925311", "3009155756", "3019837962", "3002777243", "3008237827", "2915796", "3015529000", "3016837106", "3017170972", "3016611336", "3004530258", "3017098905", "3010594620", "3018771894", "3003083993", "3009443851", "3009207631", "3011781554", "3021269066", "3009238284", "3005695808", "3016764932", "3002806560", "3016763307", "3013540184", "3028944399", "3015542780", "3005748564", "3002806559", "3007420875", "3027518847", "2025606", "3004141078", "3006198300", "3013756523", "3000210620", "3013548521", "3004417597", "3007808978", "3010791816", "3016733849", "3010030414", "3017434950", "3002524000", "3002807666", "3009214950", "3020831613", "3003413192", "3001421318", "3009573214", "3007143373", "3009875001", "3003795116", "3010031137", "3045058049", "3008937712", "3012259842", "1119779", "3003402518", "3007287152", "3013496958", "1000532580", "3017583200", "1550222", "3038622676", "3009391812", "3021043070", "3016619649", "3028240331", "3002622561", "3015980628", "3014325803", "3005248192", "3004013603", "2024800", "3002821232", "3016764493", "3006786907", "3007054022", "3017358793", "3014290238", "3003261083", "3009311010", "3016998616", "3003673482", "3003335080", "3018779125", "3026035655", "3016068451", "3013096769", "3016635427", "3002808498", "3007699074", "3014100717", "1000513605", "1318994" ], "device_name": "Clinical Sample Concentrator", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2310", "device_class": "1" } } ] }