{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "219495", "product_res_number": "Z-2331-2026", "event_date_initiated": "2026-04-13", "event_date_posted": "2026-06-05", "recall_status": "Open, Classified", "res_event_number": "98695", "product_code": "FRC", "k_numbers": [ "K032914", "K050591" ], "product_description": "Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS\nProduct Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS\nModel/Catalog Number: 1023780\nSoftware Version: N/A\nProduct Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes.\nThe test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access.\nComponent: N/A", "code_info": "Lot Code: Please see attached spreadsheet listing products that were not incubated per the following requirements :\na. Spore strips used in steam sterilizers are incubated for 24 hours\nb. Spore strips used in chemiclave sterilizers are incubated for 72 hours\nc. Spore strips used in dry heat or ethylene oxide sterilizers are incubated for 7 days\n\nAs noted in the recall scope question, HealthFirst's Field Correction scope will be expanded to include notifications to all customers in possession of 1023780 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS,1023770 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS or other products serviced by Mesa Labs.\n\nProduct/Item Number: 1023780\nUDI-DI code: 00850065007496\nLot Numbers:\nDSS-122\nDSS-125\nDSS-128\nDSS-131\nDSS-134", "firm_fei_number": "3014534", "recalling_firm": "HF Acquisition Co LLC", "address_1": "11629 49th Pl W", "city": "Mukilteo", "state": "WA", "postal_code": "98275-4255", "additional_info_contact": "TRACY MELTON\n800-3311984", "reason_for_recall": "Due to incorrect incubation process being performed on product.", "root_cause_description": "Under Investigation by firm", "action": "On 04/13/2026, the firm emailed an \"URGENT: Medical Device Field Correction\" Letter to customers informing them that the firm has identified a laboratory testing service error associated with 1023780 SporeTraq\" Mail-In Spore Testing Service, 52 Tests affecting customers using Dry Heat, Chemiclave and Ethylene Oxide autoclave types. Specifically, the incubation criteria applied to the test samples may not have complied with the above requirement for the respective autoclave type. Failure to adhere to appropriate incubation criteria impacts the validity of sterilization process followed at customer locations.\n\nCustomers are instructed to:\n1. Log into your OnTraq\" account at ontraq.healthfirst.com.\n2. A banner will appear stating ACTION REQUIRED: Review to confirm or update your autoclave types. Go to the Confirmations Page. prompting you to verify the autoclave type.\n3. Verify that the autoclave type is accurate by clicking the \"Go to the Confirmations Page\" hyperlink or navigating to \"Confirm Autoclave Type\" tab\n - If all information is accurate as it is, click on the CONFIRM button.\n - If not, edit by clicking the pencil icon next to the relevant data field, enter the updated information and click on the SAVE button.\n - If the autoclave is no longer in use, click the DEACTIVATE button and confirm the action in the pop-up window.\n4. If the above actions were completed prior to receipt of this notification via email, mail or telephone, no further action is required.\n\nFor questions - contact Customer Service at 855-476-1342 or email us at customerservice@healthfirst.com.", "product_quantity": "2210", "distribution_pattern": "U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, and WI.", "openfda": { "k_number": [ "K213296", "K090569", "K930683", "K894398", "K042450", "K884615", "K032914", "K171003", "K221641", "K141244", "K192025", "K994381", "K041386", "K122044", "K123017", "K083665", "K223715", "K170039", "K800029", "K020205", "K854902", "K121484", "K202879", "K172752", "K241959", "K171287", "K091950", "K140589", "K223023", "K810930", "K031012", "K921909", "K895704", "K192001", "K141312", "K905425", "K103321", "K192550", "K181686", "K171587", "K231490", "K173626", "K872867", "K111150", "K112018", "K173634", "K170427", "K960790", "K863122", "K073244", "K193154", "K800482", "K170070", "K792649", "K891366", "K200126", "K200996", "K173519", "K173435", "K090514", "K133549", "K971430", "K844479", "K123546", "K213809", "K192980", "K963841", "K200970", "K854631", "K903024", "K130263", "K850144", "K200092", "K212193", "K801678", "K200766", "K004009", "K200536", "K050591", "K172748", "K923739", "K133322", "K251122", "K841583", "K173670", "K930682", "K852192", "K203560", "K051056", "K140708", "K241710", "K912796", "K111375", "K103277", "K182404", "K181429", "K173633", "K082756", "K802228", "K071537", "K190297", "K122362", "K902344", "K172432", "K211705", "K771132", "K994055", "K173437", "K172474", "K052128", "K133267", "K141238", "K240717", "K251452", "K122024", "K961721", "K163144", "K223717", "K032723", "K770953", "K070595", "K233681", "K220473", "K173584", "K092944", "K771080", "K242453", "K925745", "K152060", "K812272", "K900771", "K926364", "K160546", "K151482", "K972747", "K183294", "K182931", "K171504", "K213881", "K981497", "K173488", "K113221", "K822024", "K051173", "K832922", "K884767", "K231383", "K101910", "K242538", "K841709", "K111391", "K252680", "K093794", "K050664", "K031226", "K140392", "K141580", "K922212", "K910417", "K761015", "K890754", "K241542", "K191021", "K925496", "K020026", "K102884", "K103222", "K140620", "K041784", "K962441", "K051643", "K181434", "K140499", "K202721", "K233814", "K022706", "K250044", "K891784", "K260766", "K173629", "K243501", "K971432", "K024079", "K041099", "K111515", "K121593", "K073618", "K991618", "K151585", "K183300", "K113302", "K960777", "K894399", "K092755", "K210277", "K023716", "K855120", "K993775", "K163646", "K792648", "K151971", "K092906", "K991675", "K855101", "K071014", "K250061" ], "registration_number": [ "2133641", "3036504234", "1416605", "3013557562", "1319130", "3004634710", "3013145340", "3013298431", "3016075971", "8030087", "3012494290", "3015392401", "3011061109", "2434982", "2410251", "3000251274", "3009968482", "3038718579", "3043226252", "3004080920", "2084725", "2028456", "3030733800", "3009609218", "2183301", "3012723641", "9611959", "3030626857", "3016678045", "3031841433", "3017524825", "2432141", "3012421607", "3008925937", "3031757047", "3003476474", "3014421917", "3014579161", "3007412809", "3042272797", "3013667284", "1720309", "2029076" ], "fei_number": [ "1000160630", "3005343391", "3036504234", "1416605", "3013557562", "1319130", "3004634710", "3013145340", "3013298431", "3016075971", "3012494290", "3015392401", "3011061109", "2434982", "2410251", "3000251274", "3009968482", "1000125215", "3038718579", "3003662624", "3043226252", "3004080920", "3002677549", "3014534", "3030733800", "3009609218", "2183301", "3030626857", "3000203466", "3016678045", "3031841433", "3017524825", "2432141", "3012421607", "3008925937", "3031757047", "3003476474", "3014421917", "3014579161", "3007412809", "3042272797", "3013667284", "1720309" ], "device_name": "Indicator, Biological Sterilization Process", "medical_specialty_description": "General Hospital", "regulation_number": "880.2800", "device_class": "2" } } ] }