{ "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": "95726", "product_res_number": "Z-0807-2011", "event_date_initiated": "2010-11-11", "event_date_posted": "2010-12-27", "recall_status": "Terminated", "event_date_terminated": "2013-08-23", "res_event_number": "57274", "product_code": "JPA", "k_numbers": [ "K060162" ], "product_description": "ACL ELITE PRO Coagulation Analyzer, PN 00001000311\n\nCoagulation testing.", "code_info": "Serial numbers range 05010100 - 10111779.", "firm_fei_number": "1217183", "recalling_firm": "Instrumentation Laboratory Co.", "address_1": "180 Hartwell Road", "city": "Bedford", "state": "MA", "postal_code": "01730-2443", "additional_info_contact": "781-861-4467", "reason_for_recall": "Sporadically lowered APTT results were observed with the PT/APTT Test Groups.", "root_cause_description": "Device Design", "action": "On 11/11/10, An Urgent Product Notification informing customers to discontinue use of all IL locked PT/APTT-based Test Groups was mailed to U.S. and Canadian customers, instructing them to run in Single Test or Profile Mode until further notice. The letter identified the affected product, the issue, risk and stated a list of mandatory actions. Customers are to immediately acknowledge the receipt of the notification by signing and returning it via email or fax. A Worldwide Regulatory Notice was sent on November 8, 2010 to international affiliates (non-U.S. or Canada), notifying them of the issue, providing a risk summary and the support documentation for the notification. Secondary international dealers were notified Nov 8 and a fax response of notification of the dealers will be tracked by International Laboratories. The customer notification of the secondary dealers will be handled per the local regulatory requirements of the countries where they are located.", "product_quantity": "379 in use in USA & Canada, 24 in distribution channel subject to recall", "distribution_pattern": "Worldwide Distribution -- USA, Canada, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turkmenistan, United Arabian Emirates, Uruguay, Venezuela, Vietnam, Austria, Belgium, China, France, Germany, \nHolland, Italy, Japan, Spain (and Portugal), and UK.", "openfda": { "k_number": [ "K011665", "K020798", "K082675", "K150041", "K233790", "K930068", "K030818", "K990566", "K050243", "K955735", "K792310", "K101533", "K923761", "K083896", "K900917", "K251024", "K842717", "K050016", "K934747", "K083842", "K951497", "K893650", "K832225", "K853328", "K940840", "K851153", "K151867", "K812122", "K992959", "K880713", "K926222", "K954202", "K900377", "K993678", "K970431", "K930849", "K001064", "K780810", "K870687", "K083159", "K000053", "K083175", "K853198", "K974569", "K050053", "K202101", "K994349", "K881367", "K033137", "K161317", "K002080", "K960875", "K854376", "K000973", "K883637", "K002400", "K974799", "K854090", "K232018", "K870831", "K002177", "K172286", "K853246", "K193041", "K010494", "K761171", "K852450", "K790204", "K972260", "K172333", "K862537", "K964946", "K791586", "K021162", "K011235", "K860719", "K853076", "K183390", "K853078", "K160502", "K051030", "K912061", "K990449", "K841462", "K952560", "K851127", "K924509", "K253658", "K850409", "K013114", "K912087", "K040359", "K933188", "K854546", "K984501", "K173202", "K884534", "K942097", "K050513", "K926551", "K082248", "K162420", "K853077", "K952625", "K250965", "K860342", "K864532", "K931149", "K883484", "K761176", "K761172", "K761175", "K902458", "K221359", "K980839", "K983460", "K130090", "K093001", "K924124", "K790323", "K961908", "K761173", "K864534", "K882444", "K981815", "K812124", "K083518", "K060162", "K151259", "K883689", "K933886", "K170314", "K983892", "K870688", "K854089", "K243858", "K864271", "K001067", "K900506", "K853986", "K914188", "K883640", "K854938", "K201440", "K875089", "K894359", "K955720", "K981711", "K161312", "K883635", "K951891", "K841523", "K894466", "K955724", "K940401", "K023141", "K870685", "K761091", "K760594", "K150678", "K833272", "K061014", "K212183", "K940957", "K812121", "K183160", "K870686", "K870771", "K924453", "K770606", "K925340", "K885076", "K162688", "K872377", "K942096", "K924393", "K853789", "K093167", "K870960", "K930454", "K071265" ], "registration_number": [ "3003601075", "2432235", "2026994", "3020704087", "2132111", "8043723", "1719400", "3019849102", "9613959", "3004035727", "9610806", "3006198300", "8020030", "2431530", "3005269352", "3037000637", "3015222335", "1219343", "1219738", "1618982", "3010421384", "2245451", "1644474", "3008386529", "2184009", "3010960914", "3003943960", "3007701696", "3007719797", "3009711478", "1000340866", "1217183", "3002721930", "1718389", "3005792925", "9610746", "3012348571", "3007507465", "1220649", "3010653929" ], "fei_number": [ "3003601075", "1000116158", "2432235", "2026994", "3020704087", "1719400", "3019849102", "1000140026", "3004035727", "3006198300", "3005269352", "2431530", "3037000637", "3015222335", "1219343", "3001573851", "1219738", "1618982", "3010421384", "2245451", "3008386529", "1000116989", "3010960914", "3003943960", "3007701696", "3007719797", "3009711478", "1000340866", "1217183", "1718389", "3005792925", "3001644026", "3012348571", "2250033", "3007507465", "1220649", "3002806557", "3010653929", "3006461677", "3002808301" ], "device_name": "System, Multipurpose For In Vitro Coagulation Studies", "medical_specialty_description": "Hematology", "regulation_number": "864.5425", "device_class": "2" } } ] }