{ "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": "142610", "product_res_number": "Z-0736-2016", "event_date_initiated": "2015-12-18", "event_date_posted": "2016-02-01", "recall_status": "Terminated", "event_date_terminated": "2017-08-30", "res_event_number": "72972", "product_code": "GGP", "k_numbers": [ "K981200" ], "product_description": "HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate", "code_info": "Lot No. N0455811, Expiration Date 03/31/2017", "firm_fei_number": "1217183", "recalling_firm": "Instrumentation Laboratory Co.", "address_1": "180 Hartwell Rd", "city": "Bedford", "state": "MA", "postal_code": "01730-2443", "additional_info_contact": "Ms. Carol Marble\n781-861-4467", "reason_for_recall": "This Lot is not meeting labeled on-board instrument stability claims of 5 days.", "root_cause_description": "Device Design", "action": "Instrumentation Laboratory Co. sent an \" Urgent Medical Device Removal\" letter dated December 2015, was sent on December 18, 2015. via USPS to US and Canadian customers. The notification requires US and Canadian customers to respond using a Mandatory Response Tracking Form. A Field Safety Notice was e-mailed on December 18, 2015, to the affected IL affiliates, notifying them of the product lot removal due to a stability issue and requesting them to translate the Field Safety Notice, to notify their Competent Authorities and to provide the notification to their affected customer base and secondary distributors. For further questions, please call 1(800) 955-9525.", "product_quantity": "Domestic: 108 kits, Foreign: 197 kits", "distribution_pattern": "Worldwide Distribution - US Distribution and to the countries of : Canada, Argentina, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, Italy, Lithuania, Panama, Poland, Russia, Saudi Arabia, United Kingdom, and Venezuela.", "openfda": { "k_number": [ "K842617", "K002467", "K924425", "K890409", "K053499", "K032139", "K790423", "K931906", "K870353", "K980885", "K864701", "K941752", "K922782", "K013492", "K902566", "K792507", "K834031", "K902528", "K812431", "K082631", "K181525", "K960438", "K904247", "K890634", "K002541", "K980875", "K052825", "K892859", "K860371", "K821963", "K841461", "K853462", "K952668", "K133005", "K992704", "K823267", "K832114", "K063323", "K022290", "K082205", "K841957", "K952666", "K861048", "K930327", "K832372", "K934584", "K220728", "K010963", "K051054", "K922201", "K962489", "K861159", "K954017", "K981038", "K925617", "K000398", "K983107", "K792656", "K882603", "K223402", "K882602", "K900397", "K193204", "K853461", "K872941", "K843310", "K972005", "K872479", "K913424", "K062430", "K972116", "K884551", "K042576", "K993553", "K820085", "K040987", "K974711", "K874940", "K871039", "K912025", "K962968", "K874097", "K912711", "K972482", "K884797", "K012386", "K834051", "K972342", "K792511", "K903468", "K864480", "K884058", "K861217", "K843438", "K854312", "K912468", "K900398", "K884881", "K840114", "K964270", "K791794", "K945414", "K092170", "K802356", "K870354", "K915163", "K792336", "K943225", "K914818", "K843451", "K841708", "K900399", "K834050", "K251440", "K823453", "K861049", "K983898", "K841364", "K843215", "K971985", "K942087", "K934210", "K833892", "K840329", "K070635", "K183440", "K033631", "K214002", "K884941", "K062530", "K981696", "K921449", "K000649", "K954040", "K981200", "K812975", "K952669", "K200033", "K840927", "K951640", "K013168", "K914307", "K023990", "K861079", "K950015", "K854014", "K973143", "K952126", "K792335", "K864481", "K920012", "K896174", "K050365", "K983914", "K900395", "K864497", "K964459", "K961929", "K884544", "K043571", "K792508", "K920981", "K930235", "K934314", "K812974", "K972288", "K963106", "K962825", "K011424", "K040843", "K881037", "K010379", "K870917", "K861216", "K861417", "K792476", "K230852", "K002350", "K955738", "K102164", "K971519", "K761058", "K792475", "K924884", "K840928", "K050448", "K981817", "K897136", "K884940", "K861475" ], "registration_number": [ "3003601075", "1721937", "2432235", "2518152", "9610806", "1835316", "2431530", "3037000637", "1618982", "2183608", "2245451", "3008386529", "3004737529", "3003485232", "1217183", "3003691680", "9710666", "3004434070", "9610746", "3004075036", "8043599" ], "fei_number": [ "3003601075", "2432235", "2518152", "3000210416", "2431530", "3037000637", "1618982", "2183608", "2245451", "1000117401", "3008386529", "3004737529", "3003485232", "1217183", "3003565434", "3003691680", "3004434070", "3001644026", "3004075036", "3002806557", "3005917516" ], "device_name": "Test, Qualitative And Quantitative Factor Deficiency", "medical_specialty_description": "Hematology", "regulation_number": "864.7290", "device_class": "2" } } ] }