{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "218594", "product_res_number": "Z-1491-2026", "event_date_initiated": "2026-02-04", "event_date_posted": "2026-03-03", "recall_status": "Open, Classified", "res_event_number": "98394", "product_code": "GGP", "k_numbers": [ "K010963" ], "product_description": "Brand Name: STA Liatest Free Protein S\nProduct Name: STA Liatest Free Protein S\nModel/Catalog Number (REF): 00516\nProduct Description: The STA - Liatest Free Protein S kits are intended for use on STA-R and STA Compact for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method.\nComponent: Not Applicable", "code_info": "Model/Catalog Number (REF): 00516;\nUDI: (1) (01)03607450005165(11)241001(17)260131(10)271971(241)00516, (2) (01)03607450005165(11)250221(17)260531(10)272859(241)00516, (3) (01)03607450005165(11)250306(17)260630(10)273018(241)00516, (4) (01)03607450005165(11)250430(17)260831(10)273426(241)00516;\n\nLot numbers: (1) 271 971, (2) 272 859, (3) 273 018, (4) 273 426;\nLot Code: 271 971 (01)03607450005165(11)241001(17)260131(10)271971(241)00516", "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": "The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.", "root_cause_description": "Under Investigation by firm", "action": "On February 4, 2026 URGENT: MEDICAL DEVICE RECALL (REMOVAL) letters were sent to customers. Actions required: If you currently have one or more kits of STA LIATEST FREE PROTEIN S 6 :\n- For REF 00516: Lots 271971, 272859, and 273018 with a short expiration date we ask you to discontinue their use and dispose of them in accordance with your local regulations. Stago will provide a credit for any destroyed kits.\n- For REF 00516: lot 273426:\no If the initial barcode sheet provided with the kit has already been loaded into the\ninstrument:\n- Stop the use the initial barcode pre-calibration settings.\n- Replace the initial barcode settings with the new pre-calibration barcode settings\nattached, by following to the procedure described in Appendix 1 of this letter.\no If the initial barcode sheet has not yet been loaded into the instrument:\n- Do not use it and proceed to load the lot using the new pre-calibration barcodes\nprovided in the attachment.", "product_quantity": "369", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MI, MN, MO, MT, NC, ND, NJ, NY, OH, PA, TN, TX, UT, VA, WA and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BIELORUSSIE, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COSTA RICA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, GUATEMALA, INDIA, IRAQ, IRELAND, ITALY, JORDAN, KENYA, KOREA REPUBLIC OF, LITUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PAKISTAN, PALESTINIAN TERRITORY, PARAGUAY, PORTUGAL, ROMANIA, RUSSIE, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIE, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY;", "openfda": { "k_number": [ "K133005", "K013168", "K812974", "K930235", "K964459", "K251440", "K992704", "K870354", "K183440", "K941752", "K833892", "K841957", "K971985", "K840928", "K951640", "K882603", "K952668", "K000398", "K924425", "K223402", "K980885", "K002467", "K181525", "K903468", "K043571", "K082631", "K010963", "K834050", "K823267", "K854312", "K860371", "K861079", "K871039", "K062530", "K902528", "K854014", "K792656", "K802356", "K972005", "K872479", "K884940", "K042576", "K792511", "K022290", "K884544", "K864701", "K861159", "K861216", "K792508", "K230852", "K870353", "K013492", "K972116", "K925617", "K961929", "K792476", "K861217", "K973143", "K971519", "K934314", "K874940", "K791794", "K843451", "K002350", "K890409", "K924884", "K890634", "K062430", "K981817", "K843438", "K853462", "K913424", "K922782", "K051054", "K912025", "K792336", "K983914", "K000649", "K900398", "K983107", "K821963", "K761058", "K040843", "K950015", "K963106", "K864481", "K050365", "K092170", "K823453", "K040987", "K972482", "K050448", "K904247", "K872941", "K834031", "K792507", "K960438", "K945414", "K882602", "K884941", "K902566", "K931906", "K002541", "K981696", "K011424", "K881037", "K832372", "K070635", "K900397", "K834051", "K841364", "K952126", "K981200", "K921449", "K023990", "K032139", "K934210", "K864497", "K820085", "K200033", "K943225", "K897136", "K912711", "K974711", "K861048", "K964270", "K952666", "K954017", "K792335", "K010379", "K840329", "K841708", "K861417", "K843215", "K915163", "K053499", "K993553", "K912468", "K790423", "K841461", "K884797", "K193204", "K962825", "K012386", "K884551", "K920012", "K082205", "K884058", "K983898", "K840927", "K920981", "K214002", "K853461", "K900399", "K954040", "K934584", "K052825", "K892859", "K922201", "K861049", "K102164", "K874097", "K972342", "K972288", "K900395", "K840114", "K962968", "K981038", "K980875", "K952669", "K033631", "K063323", "K930327", "K884881", "K896174", "K864480", "K843310", "K942087", "K812975", "K812431", "K955738", "K792475", "K861475", "K962489", "K220728", "K914307", "K914818", "K842617", "K870917", "K832114" ], "device_name": "Test, Qualitative And Quantitative Factor Deficiency", "medical_specialty_description": "Hematology", "regulation_number": "864.7290", "device_class": "2", "registration_number": [ "9610746", "3008386529", "1217183", "1721937", "2518152", "3003601075", "1618982", "9710666", "3003485232", "9610806", "3003691680", "8043599", "3004075036", "3004434070", "2431530", "2245451", "2432235", "2183608", "3004737529", "3037000637", "1835316" ], "fei_number": [ "3008386529", "1217183", "2518152", "3003565434", "3003601075", "3001644026", "1618982", "1000117401", "3003485232", "3005917516", "3003691680", "3004075036", "3004434070", "2431530", "2245451", "2432235", "2183608", "3004737529", "3037000637", "3002806557", "3000210416" ] } } ] }