{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198359", "product_res_number": "Z-1227-2023", "event_date_initiated": "2023-02-01", "event_date_posted": "2023-03-06", "recall_status": "Open, Classified", "res_event_number": "91618", "product_code": "GGP", "k_numbers": [ "K050365" ], "product_description": "BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac (Agkistrodom Contortrix), an enzyme extracted from snake venom. Activated protein C hydrolysis the chromogenic substrate (SaPC-21) which release para-nitroaniline (pNA). The amount of pNA released (measured by absorbance at 405 nm) is directly proportional to the concentration of Protein C in the specimen.", "code_info": "UDI-DI: 366353700063BD\nLot FA083327 (And all future lots)", "firm_fei_number": "3005017664", "recalling_firm": "Aniara Diagnostica LLC", "address_1": "7768 Service Center Dr", "city": "West Chester", "state": "OH", "postal_code": "45069-2442", "additional_info_contact": "SAME\n513-770-1993", "reason_for_recall": "New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which changed classification and has become hazardous according to the CLP regulation ((EC) No 1272/2008) is suspected of damaging fertility", "root_cause_description": "Other", "action": "Aniara issued Medical Field Correction Letter (FSCA#29) prepared by HYPHEN BioMed and emailed to the customer by Aniara Diagnostica on 2/1/23.\nLetter states reason for recall, health risk and action to take:\nNew labelling will be implemented on all new lots as follow:\nx A new pictogram added on reagent and box label: GHS08\nx Signal Word: Warning\nx Hazard Statements: H361f - Suspected of damaging fertility\n\nx Precautionary Statements:\no P201 : Obtain special instructions before use.\no P280 : Wear protective gloves/protective clothing/eye protection/face protection.\no P308 + P313 : IF exposed or concerned: Get medical advice/attention.\no P405 : Store locked up.\no P501 : Dispose of contents/container in consultation with your regional waste disposer\nx Hazardous ingredients : Cesium chloride\nThe IFU, label and SDS will be updated.\n\nPlease return completed and signed Form to your distributor.", "product_quantity": "2 units", "distribution_pattern": "US Nationwide distribution in the state of NC.", "openfda": { "k_number": [ "K013168", "K792476", "K915163", "K971985", "K792511", "K870917", "K954040", "K954017", "K870354", "K791794", "K864701", "K853462", "K943225", "K841957", "K052825", "K964270", "K802356", "K952666", "K902566", "K840928", "K902528", "K062530", "K833892", "K962968", "K011424", "K961929", "K842617", "K896174", "K841461", "K955738", "K874097", "K921449", "K963106", "K010379", "K952669", "K981038", "K051054", "K834050", "K980875", "K981696", "K874940", "K200033", "K920012", "K050448", "K981200", "K861079", "K914818", "K922782", "K872479", "K841364", "K812431", "K133005", "K951640", "K884551", "K812975", "K792336", "K792656", "K183440", "K972288", "K792475", "K900399", "K864481", "K823453", "K843215", "K043571", "K010963", "K882603", "K864497", "K843310", "K861216", "K840329", "K900397", "K903468", "K002541", "K050365", "K920981", "K002350", "K854312", "K871039", "K840114", "K884058", "K820085", "K890409", "K002467", "K832372", "K062430", "K063323", "K012386", "K900398", "K864480", "K854014", "K102164", "K922201", "K070635", "K861417", "K193204", "K761058", "K971519", "K092170", "K181525", "K082631", "K214002", "K931906", "K972005", "K040987", "K832114", "K861159", "K945414", "K834031", "K823267", "K897136", "K962825", "K974711", "K934210", "K972342", "K861049", "K220728", "K960438", "K033631", "K941752", "K053499", "K082205", "K230852", "K882602", "K884881", "K251440", "K872941", "K930235", "K992704", "K930327", "K792507", "K000649", "K032139", "K972116", "K023990", "K964459", "K860371", "K884940", "K870353", "K792335", "K884941", "K834051", "K821963", "K790423", "K904247", "K980885", "K934314", "K892859", "K900395", "K853461", "K913424", "K924425", "K983107", "K950015", "K912025", "K840927", "K841708", "K792508", "K861048", "K040843", "K934584", "K022290", "K983914", "K884544", "K843438", "K993553", "K042576", "K861217", "K942087", "K952668", "K912711", "K962489", "K223402", "K914307", "K812974", "K983898", "K972482", "K843451", "K981817", "K924884", "K925617", "K000398", "K861475", "K912468", "K884797", "K881037", "K013492", "K952126", "K890634", "K973143" ], "device_name": "Test, Qualitative And Quantitative Factor Deficiency", "medical_specialty_description": "Hematology", "regulation_number": "864.7290", "device_class": "2", "registration_number": [ "3003601075", "3003485232", "1217183", "9710666", "9610806", "2431530", "1721937", "3004434070", "2245451", "9610746", "3037000637", "3004075036", "2432235", "3004737529", "1835316", "8043599", "2183608", "1618982", "2518152", "3008386529", "3003691680" ], "fei_number": [ "3005917516", "3003601075", "3003485232", "1217183", "2431530", "1000117401", "3004434070", "2245451", "3037000637", "3004075036", "2432235", "3004737529", "2183608", "3001644026", "1618982", "2518152", "3008386529", "3003565434", "3000210416", "3003691680", "3002806557" ] } } ] }