{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "139579", "product_res_number": "Z-0166-2016", "event_date_initiated": "2015-08-24", "event_date_created": "2015-10-26", "recall_status": "Terminated", "event_date_terminated": "2021-01-21", "res_event_number": "72013", "product_code": "JQP", "product_description": "Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.", "code_info": "Software Version 1.6", "firm_fei_number": "3002808498", "recalling_firm": "Perkin Elmer Life Sciences Inc", "address_1": "Laitun 4 Mustionkatu 6 6 laitun mustionkatu", "city": "Turku", "country": "Finland", "reason_for_recall": "It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the interpretation of the test result value would be incorrect.", "root_cause_description": "Software design", "action": "Perkin Elmer issued the Recall Letter on 8/24/15 delivered to the customer by email .Software Services will be asked to make sure the customers receive the Recall Letter and implement the recommended corrective measures: \nEnsure all laboratory routine sample testing procedures are followed to avoid procedural anomalies. In the event a procedure anomaly occurs, review the final analytical result and the corresponding interpretation to confirm both are accurate before releasing the report. Once a PerkinElmer reporting error query is available, continue to run the query until the final corrective action is deployed to your site. \nThe final corrective action will involve an installation update to the software.\nFor further information, please contact your local PerkinElmer representative or specimen.gate.support@perkinelmer.com", "product_quantity": "6 units", "distribution_pattern": "US distribution to FL, GA, and NV; and Canada", "openfda": { "k_number": [ "K833353", "K803312", "K871853", "K832746", "K861412", "K810631", "K823785", "K831574", "K822381", "K113007", "K821058", "K831830", "K801167", "K831838", "K861844", "K861778", "K801664", "K800242", "K822778", "K822932", "K934111", "K822860", "K844907", "K885292", "K834490", "K923316", "K802594", "K842401", "K812604", "K781081", "K760739", "K864557", "K834300", "K790336", "K781173", "K964460", "K800724", "K892060", "K881194", "K820427", "K871339", "K821807", "K810063", "K830296", "K792158", "K851321", "K802471", "K770671", "K850659", "K801210", "K823679", "K781217", "K761063", "K790543", "K823110", "K801438", "K780881", "K853026", "K832760", "K861779", "K782052", "K983468", "K953652", "K770877", "K800282", "K843365", "K802251", "K800241", "K801131", "K792129", "K821531", "K840502", "K893838", "K801091", "K810968", "K822146", "K854265", "K820721" ], "registration_number": [ "3003795116", "3043012074", "3015426626", "3002809144", "9610865", "2432235", "3031570369", "3004032053", "3005798890", "3015058854", "9610126", "3003618481", "3015633428", "3011194542", "3006543086", "3004145393", "3011806823", "3015347724", "3017086896", "3040278125", "3013896610", "3011121740", "3009404844", "3003825930", "3002637618", "2029302", "3006371704", "1810909", "3006755541", "2431530", "3004959793", "3043012240", "3027486032", "9710492", "3038419886", "3042228064", "1000113657", "3009129531", "8020888", "3005509212", "9616936", "3003600763", "3013922172", "1219145", "3016764932", "3010097171", "3010258456", "3010141591", "9615754", "3006677029", "3011393376", "3002807715", "2245451", "3009731198", "3013298431", "3042989733", "1225673", "3016438761", "3024512705", "3013646951", "2936921", "9610816", "3030413550", "1061932", "3021394862", "3037000637", "3020978007", "3009711478", "3010900203", "9615507", "1119779", "3005333358", "3023268435", "3003559191", "8030392", "3004838836", "3002710220", "1950204", "3012118659", "3003995437", "3008514395", "3011187792", "3027496319", "3003902721", "3015967359", "2243471", "3002889627", "3005862821", "8043909", "3007134734", "3009288740", "2954323", "3025376092", "3012104009", "3015738702", "3035708936", "8020030", "3010825766", "1058332", "1220649", "3008789114", "9614673", "3002821232", "3012436569", "3014840402", "2531491", "3030714692", "3009542936", "3015969360", "3004973408", "3000148879", "2517506", "9616530", "3003453957", "8043723", "3000126629", "3008802064" ], "fei_number": [ "3003795116", "3043012074", "3015426626", "3002809144", "2432235", "3031570369", "3004032053", "3005798890", "3015058854", "3003516723", "3003618481", "3015633428", "3011194542", "3006543086", "3004145393", "3011806823", "3015347724", "3017086896", "3040278125", "3013896610", "3003500908", "3009404844", "3001451449", "3003825930", "3002637618", "3006371704", "3003116995", "1810909", "3002808498", "3006755541", "3003559576", "3006461677", "2431530", "3004959793", "3002807167", "3007019572", "3001573851", "3043012240", "3027486032", "3042228064", "3038419886", "1000113657", "1000307651", "3009129531", "3005509212", "3003600763", "3013922172", "1219145", "3016764932", "3002829675", "3010097171", "3010258456", "3010141591", "3006677029", "3011393376", "3002807715", "2245451", "3009731198", "3013298431", "3042989733", "3016438761", "3024512705", "3013646951", "2936921", "3030413550", "3021394862", "3037000637", "3009711478", "3020978007", "3010900203", "1119779", "3005333358", "3023268435", "3003559191", "3004838836", "3002710220", "1950204", "3012118659", "3003995437", "3008514395", "3011187792", "3027496319", "3003902721", "3002806559", "3002671736", "3015967359", "3002806350", "3002803444", "2243471", "3002889627", "3005862821", "3007134734", "3009288740", "3025376092", "3000203293", "3012104009", "3015738702", "3035708936", "3010825766", "3008237827", "3010700165", "1220649", "3008789114", "3002821232", "3012436569", "3014840402", "3030714692", "3009542936", "3015969360", "3004973408", "3000148879", "2517506", "3003453957", "1000306472", "3000126629", "3008802064" ], "device_name": "Calculator/Data Processing Module, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ] }