{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221230", "product_res_number": "Z-2854-2026", "event_date_initiated": "2026-06-16", "event_date_posted": "2026-07-31", "recall_status": "Open, Classified", "res_event_number": "99302", "product_code": "JQP", "product_description": "Brand Name: WASPLab\nProduct Name: WASPLab\nModel/Catalog Number: W087\nSoftware Version: WebApp version 2.33.1, 2.33.3 and 2.34.2\nProduct Description: WASPLab is an automated device intended to be used for the incubation and the digital imaging of agar culture plates streaked with microbiological specimens derived by the human body for microbiological investigations. WebApp software is the user interface of WASPLab device.", "code_info": "Lot Code: WebApp version 2.33.1, 2.33.3 and 2.34.2", "firm_fei_number": "3009288740", "recalling_firm": "Copan WASP", "address_1": "Via Achille Grandi, 32 32 via achille grandi", "city": "Brescia", "country": "Italy", "reason_for_recall": "Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.", "root_cause_description": "Under Investigation by firm", "action": "On 06/16/2026, an \"URGENT MEDICAL DEVICE RECALL\" Letter was provided to customers informing them that, A software bug has been identified in the WebApp software which, under specific\nconditions, may prevent the result suggested by PhenoMATRIX from being overwritten\nby the result selected by the user. As a consequence, the result transmitted by WASPLab\nto the LIS may be the result suggested by PhenoMATRIX, rather than the result selected\nby the user.\n\nCustomers were informed and instructed:\nIn date 2026/06/15 we released a WebApp software version including the bugfix of this\nissue. As a consequence, you are required to schedule with your distributor the software\nupdate to correct the issue and, in the meanwhile, to check the results sent to LIS in\ncase you changed the result suggested by PhenoMATRIX.\n\nComplete the attached Customer Response Form and return to the Copan WASP\nSrl contact noted on the form so that Copan WASP Srl may acknowledge your receipt of this notification.\n\nFor questions or further assistance email regulatory.wasp@copangroup.com", "product_quantity": "1", "distribution_pattern": "US Nationwide distribution in the state of Arizona.", "openfda": { "k_number": [ "K851321", "K834490", "K802251", "K781081", "K832746", "K834300", "K831838", "K844907", "K853026", "K861778", "K782052", "K871339", "K831574", "K885292", "K842401", "K800724", "K770671", "K822932", "K801167", "K781173", "K861844", "K831830", "K822860", "K822146", "K832760", "K802471", "K801438", "K792129", "K823679", "K113007", "K810063", "K760739", "K861779", "K821531", "K802594", "K892060", "K833353", "K821807", "K801210", "K801131", "K790543", "K812604", "K821058", "K830296", "K770877", "K803312", "K800282", "K801664", "K820721", "K964460", "K823110", "K953652", "K801091", "K790336", "K864557", "K822381", "K800242", "K822778", "K780881", "K820427", "K893838", "K810968", "K854265", "K871853", "K843365", "K850659", "K983468", "K761063", "K792158", "K923316", "K810631", "K781217", "K823785", "K800241", "K840502", "K881194", "K861412", "K934111" ], "registration_number": [ "2531491", "3003559191", "1219145", "2954323", "3014840402", "3015633428", "3023268435", "3042989733", "3011187792", "3008802064", "3027496319", "3005798890", "3010258456", "3035708936", "3010900203", "3002889627", "3008789114", "9610126", "3012118659", "3004032053", "3037000637", "2517506", "2029302", "3015967359", "3005862821", "3025376092", "3013922172", "3015426626", "3013298431", "1225673", "3011121740", "9610816", "9615507", "3011806823", "3040278125", "9614673", "3013646951", "3009129531", "1220649", "2432235", "3016764932", "9610865", "3027486032", "3043012240", "3015969360", "8030392", "8020888", "9710492", "3015347724", "3004959793", "3006543086", "3003902721", "2243471", "9616936", "3003825930", "3008514395", "3002821232", "3003600763", "3006677029", "3015058854", "3003795116", "3015738702", "3009731198", "3020978007", "3004838836", "3003453957", "3038419886", "3002809144", "3021394862", "9615754", "2245451", "3043012074", "3009542936", "1119779", "3004145393", "3006371704", "1058332", "3013896610", "3010141591", "3031570369", "3030714692", "3004973408", "3024512705", "3042228064", "3005509212", "8020030", "2431530", "9616530", "3030413550", "3012436569", "3009288740", "3011194542", "3003618481", "3007134734", "1810909", "8043909", "3002807715", "2936921", "3010097171", "3002710220", "3002637618", "1950204", "3011393376", "3000126629", "3009404844", "3000148879", "3010825766", "3016438761", "1061932", "3003995437", "3017086896", "3009711478", "3012104009", "8043723", "1000113657", "3005333358", "3006755541" ], "fei_number": [ "3003559191", "1219145", "3014840402", "3015633428", "3023268435", "3042989733", "3011187792", "3008802064", "3027496319", "3005798890", "3010258456", "3035708936", "3010900203", "3002889627", "3008789114", "3012118659", "3004032053", "3003559576", "3037000637", "2517506", "3003500908", "3000203293", "3015967359", "3005862821", "3002806559", "3013922172", "3025376092", "3015426626", "1000307651", "3013298431", "3011806823", "3040278125", "3013646951", "3009129531", "1220649", "2432235", "3016764932", "3027486032", "3043012240", "3015969360", "3015347724", "3004959793", "3006543086", "3003902721", "2243471", "3003825930", "3008514395", "3003600763", "3002821232", "3006677029", "3015058854", "3003795116", "3015738702", "3009731198", "3008237827", "3020978007", "3004838836", "3003453957", "3038419886", "3002809144", "3021394862", "3002808498", "2245451", "3043012074", "3009542936", "3006461677", "1119779", "3004145393", "3006371704", "3013896610", "3010141591", "3031570369", "3002671736", "3002807167", "3030714692", "3004973408", "3024512705", "3042228064", "3005509212", "3001573851", "2431530", "3030413550", "3012436569", "3009288740", "3011194542", "3003618481", "3007134734", "1810909", "3007019572", "3002807715", "2936921", "3010097171", "3002710220", "3002637618", "1950204", "3011393376", "3002829675", "3000126629", "3010700165", "3009404844", "3000148879", "3010825766", "3016438761", "3003995437", "3017086896", "3009711478", "3001451449", "3012104009", "1000113657", "3003516723", "3005333358", "3003116995", "3006755541", "3002803444", "3002806350", "1000306472" ], "device_name": "Calculator/Data Processing Module, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ] }