{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221774", "product_res_number": "Z-3047-2026", "event_date_initiated": "2026-07-29", "event_date_posted": "2026-08-28", "recall_status": "Open, Classified", "res_event_number": "99531", "product_code": "GGP", "k_numbers": [ "K913424" ], "product_description": "STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; \nqualitative and quantitative factor deficiency test", "code_info": "UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027", "firm_fei_number": "2245451", "recalling_firm": "Diagnostica Stago, Inc.", "address_1": "5 Century Dr", "city": "Parsippany", "state": "NJ", "postal_code": "07054-4607", "additional_info_contact": "Technical Hotline\n800-7250607", "reason_for_recall": "A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified", "root_cause_description": "Under Investigation by firm", "action": "Diagnostica Stago issued an URGENT: MEDICAL DEVICE RECALL (REMOVAL) notice to its consignees on 7/29/2026 via email. The notice described the issue, risk assessment, and requested the following: \n\"Actions Required\nTo prevent potential workflow disruptions associated with the increased recalibration frequency, we request that you:\n\"\tImmediately discontinue use of STA-Staclot Protein S, Lot 273074.\n\"\tDispose of any remaining inventory of the affected lot in accordance with your facility's procedures and local regulations.\n\"\tComplete, sign, and return the enclosed Acknowledgement Form by email to confirm receipt and understanding of this notification. \nStago will provide a credit for the destroyed kits you indicate on the Acknowledgement Form.\" \nFor questions regarding this notice or require assistance, please contact Stago's 24/7 Hotline at 1-800-725-0607.", "product_quantity": "5220 units", "distribution_pattern": "US Nationwide distribution in the states and territory of NJ, NY, NJ, VA, PA, FL, AL, GA, TN, OH, IL, MO, NE, TX, CO, UT, CA, PR.", "openfda": { "k_number": [ "K884544", "K042576", "K983107", "K890634", "K834050", "K896174", "K951640", "K792507", "K833892", "K843310", "K000398", "K040843", "K992704", "K821963", "K981696", "K051054", "K070635", "K864701", "K792335", "K904247", "K050365", "K981038", "K882602", "K861216", "K874097", "K941752", "K861049", "K861079", "K961929", "K082631", "K874940", "K013168", "K214002", "K012386", "K903468", "K853462", "K962489", "K853461", "K834031", "K861475", "K914818", "K840928", "K942087", "K983914", "K792475", "K861048", "K962968", "K934210", "K181525", "K843215", "K022290", "K913424", "K972005", "K792511", "K912711", "K952668", "K223402", "K842617", "K010963", "K840927", "K864497", "K133005", "K834051", "K902566", "K952669", "K063323", "K890409", "K912025", "K792476", "K812975", "K792656", "K002467", "K920012", "K841461", "K043571", "K915163", "K062430", "K945414", "K983898", "K861159", "K930327", "K092170", "K761058", "K251440", "K900399", "K861217", "K922782", "K943225", "K882603", "K931906", "K823267", "K023990", "K934584", "K841957", "K861417", "K884058", "K870917", "K183440", "K897136", "K010379", "K972116", "K220728", "K921449", "K050448", "K832372", "K950015", "K792336", "K922201", "K032139", "K900395", "K902528", "K981817", "K900398", "K884941", "K854312", "K864481", "K872941", "K964459", "K980875", "K900397", "K002350", "K870354", "K102164", "K013492", "K872479", "K870353", "K843451", "K812431", "K954040", "K871039", "K974711", "K952126", "K971519", "K962825", "K840329", "K854014", "K802356", "K925617", "K841708", "K964270", "K820085", "K973143", "K892859", "K864480", "K884797", "K823453", "K955738", "K002541", "K011424", "K884940", "K841364", "K930235", "K972342", "K924884", "K033631", "K052825", "K812974", "K884551", "K860371", "K972482", "K792508", "K914307", "K791794", "K230852", "K062530", "K963106", "K954017", "K912468", "K993553", "K843438", "K924425", "K200033", "K971985", "K000649", "K881037", "K840114", "K053499", "K884881", "K193204", "K920981", "K082205", "K952666", "K980885", "K040987", "K934314", "K981200", "K972288", "K960438", "K832114", "K790423" ], "device_name": "Test, Qualitative And Quantitative Factor Deficiency", "medical_specialty_description": "Hematology", "regulation_number": "864.7290", "device_class": "2", "registration_number": [ "2432235", "9610746", "2518152", "3003601075", "3003485232", "9710666", "2245451", "3003691680", "1835316", "2183608", "3004737529", "9610806", "1721937", "1618982", "1217183", "3037000637", "2431530", "8043599", "3008386529", "3004075036", "3004434070" ], "fei_number": [ "2432235", "3002806557", "3003565434", "2518152", "3003601075", "3003485232", "3000210416", "3001644026", "2245451", "1000117401", "3003691680", "2183608", "3004737529", "3004075036", "1618982", "1217183", "3037000637", "2431530", "3008386529", "3005917516", "3004434070" ] } } ] }