{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 13 } }, "results": [ { "cfres_id": "167256", "product_res_number": "Z-0106-2019", "event_date_initiated": "2017-04-04", "event_date_created": "2018-10-12", "recall_status": "Terminated", "event_date_terminated": "2020-05-14", "res_event_number": "81024", "product_code": "GGP", "k_numbers": [ "K972482" ], "product_description": "\"Free and Total Protein S ELISA Kit\" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Reference Plasma, 1x12 mL Protein S Conjugate Solution, 1 x 60mL Sample Diluent, 1 x 13mL Substrate, 1 x 15mL Stopping Solution, 1 x 30mL Phosphate Buffered Saline, 1 x 2mL Free Protein S Reagent FOR IN-VITRO DIAGNOSTIC USE LOT: 3-16- 5292 EXP: 2018-01-26 HELENA LABORATORIES BEAUMONT, TX\n\nOuter labeling of Substrate (brown bottle and cap):\n\"Substrate 13 mL\" FOR IN-VITRO DIAGNOSTIC USE\nStore at 2 to 8 C\nHELENA LABORATORIES Beaumont, Tx \n\"2161421 EXP: 2018-01-26\"\n\nOuter Labeling of Protein S Conjugate bottle (clear bottle and cap, red liquid):\n\"Protein S Conjugate 12 mL\" FOR IN-VITRO DIAGNOSTIC USE\nStore at 2 to 8 C\nHELENA LABORATORIES Beaumont, Tx \n\"2161421 EXP: 2018-01-26\"", "code_info": "3-16-5292; UDI: Primary DI - M52552920", "firm_fei_number": "1618982", "recalling_firm": "Helena Laboratories, Inc.", "address_1": "1530 Lindbergh Dr", "city": "Beaumont", "state": "TX", "postal_code": "77707-4131", "additional_info_contact": "Dr. Jessica Jones Hanka\n409-842-3714 Ext. 1177", "reason_for_recall": "Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate.", "root_cause_description": "Labeling mix-ups", "action": "On 4/4/17, an email notification was initially sent to the firm's OUS distributor that received 3 kits. On 4/10/17, the customer replied with a photograph to confirm their kits were affected. A Withdrawal notice was approved internally, and formally issued by the firm to a single distributor via e-mail on 4/17/17. An authorized confirmation of destruction was sent from the distributor to the firm via e-mail on 4/18/17. The firm's public contact may be reached at (409) 842-3714 ext. 1177.", "product_quantity": "3 kits", "distribution_pattern": "International distribution to country of: Jordan", "openfda": { "k_number": [ "K010963", "K884551", "K092170", "K892859", "K920012", "K981817", "K960438", "K012386", "K904247", "K820085", "K102164", "K223402", "K924884", "K133005", "K952669", "K934314", "K900395", "K871039", "K791794", "K181525", "K920981", "K914818", "K843215", "K854014", "K792656", "K841708", "K050365", "K897136", "K981200", "K010379", "K193204", "K812974", "K980875", "K843451", "K052825", "K954040", "K050448", "K983914", "K981696", "K823267", "K971519", "K870354", "K000398", "K962968", "K000649", "K251440", "K053499", "K884941", "K841461", "K834050", "K834051", "K833892", "K964459", "K971985", "K983107", "K884881", "K972482", "K983898", "K931906", "K062530", "K082631", "K040843", "K043571", "K220728", "K900397", "K922201", "K792511", "K943225", "K874097", "K961929", "K861216", "K861049", "K864480", "K962489", "K914307", "K890409", "K903468", "K843310", "K812431", "K013492", "K922782", "K063323", "K872479", "K812975", "K963106", "K900398", "K070635", "K853462", "K792508", "K843438", "K840329", "K854312", "K792476", "K912711", "K002350", "K840927", "K924425", "K840114", "K884940", "K945414", "K912025", "K884544", "K954017", "K792507", "K972005", "K973143", "K980885", "K952126", "K955738", "K952668", "K183440", "K864701", "K853461", "K884058", "K934584", "K915163", "K200033", "K040987", "K842617", "K972288", "K023990", "K834031", "K861417", "K860371", "K884797", "K032139", "K841957", "K974711", "K861159", "K033631", "K840928", "K902566", "K864481", "K872941", "K002541", "K792335", "K962825", "K930235", "K002467", "K952666", "K951640", "K214002", "K802356", "K823453", "K925617", "K870917", "K882603", "K890634", "K861048", "K882602", "K841364", "K022290", "K993553", "K992704", "K941752", "K062430", "K881037", "K921449", "K790423", "K902528", "K230852", "K013168", "K874940", "K870353", "K821963", "K864497", "K964270", "K861217", "K082205", "K900399", "K912468", "K972116", "K972342", "K896174", "K934210", "K042576", "K930327", "K950015", "K761058", "K832114", "K981038", "K832372", "K792336", "K011424", "K913424", "K861475", "K942087", "K861079", "K792475", "K051054" ], "registration_number": [ "2183608", "8043599", "1618982", "3004737529", "3004434070", "1835316", "2245451", "1217183", "9710666", "9610746", "3003485232", "3037000637", "3004075036", "3003601075", "1721937", "2431530", "2518152", "2432235", "3008386529", "3003691680", "9610806" ], "fei_number": [ "2183608", "1618982", "3004737529", "3003565434", "3004434070", "2245451", "1217183", "3003485232", "3037000637", "3002806557", "3004075036", "3001644026", "3005917516", "3003601075", "2431530", "2432235", "3008386529", "3003691680", "3000210416", "1000117401", "2518152" ], "device_name": "Test, Qualitative And Quantitative Factor Deficiency", "medical_specialty_description": "Hematology", "regulation_number": "864.7290", "device_class": "2" } } ] }