{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210203", "product_res_number": "Z-0223-2025", "event_date_initiated": "2024-09-18", "event_date_posted": "2024-10-24", "recall_status": "Completed", "res_event_number": "95416", "product_code": "LCP", "k_numbers": [ "K090413" ], "product_description": "A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.", "code_info": "UDI-DI: 00381933021011\n\nLot Numbers:\n9331803, 2323019", "firm_fei_number": "3002698769", "recalling_firm": "Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.", "address_1": "4600 Anson Blvd", "city": "Whitestown", "state": "IN", "postal_code": "46075-4489", "additional_info_contact": "SAME\n317-870-5610", "reason_for_recall": "The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot number are meant to be used together, and not mixed between lots. Therefore, the test results may possibly lead to Hemoglobin A1C positive or negative bias results. While the product is for monitoring only, over recovery with a higher than accurate value can be an indication for increased therapy; such as physical activity, weight reduction, meal management, pharmaceutical therapy.", "root_cause_description": "Under Investigation by firm", "action": "PTS Diagnostics issued Urgent Medical Device Recall letter on 9/18/24 via UPS or Email. Letter states reason for recall, health risk and action to take:\n1. Return any product remaining in your control for replacement.\n2. Distributors should immediately forward this notice and response form to all\ncustomers/users who may have received this product.\n3. Acknowledge receipt of this instruction by completing the attached form, even if\nyou do not have the affected product on hand.\nPTS would like to remind customers/distributors that professional use products are\nprescription use only in the United States, meaning that federal law restricts this device to\nsale by or on the order of a licensed healthcare professional. We highly encourage you to\nmonitor the activities of your customers/resel lers.\nActions that have been taken by PTS Diagnostics:\nPTS Diagnostics has investigated this al legation and cannot confirm its veracity based on our review of retention samples, batch records, or product on hand \nBecause the customers purchased these products through an e-tailer/reseller, PTS does not know if the issue could have happened in the distribution channel.\nContact Information:\nThank you for your prompt action, and we apologize for any inconvenience this issue\nmay have caused you and your facility. If you have any questions, please contact\nCustomer Service directly, Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time\nat + 1 317-870-5610 or 877-870-5610 (U.S. toll-free).", "product_quantity": "2,452 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Japan, South Africa.", "openfda": { "k_number": [ "K842689", "K780573", "K972265", "K971919", "K121492", "K984529", "K823869", "K811000", "K050574", "K030553", "K962597", "K023654", "K130014", "K920397", "K102510", "K942009", "K952337", "K935613", "K060650", "K780819", "K834294", "K832775", "K895661", "K940971", "K791103", "K140801", "K011852", "K003280", "K983726", "K871679", "K882051", "K070819", "K031043", "K811710", "K900718", "K072714", "K912748", "K130860", "K951361", "K122472", "K033674", "K811567", "K990992", "K800857", "K871388", "K022661", "K053411", "K941616", "K042459", "K110934", "K192987", "K801422", "K802721", "K992921", "K781948", "K021897", "K884184", "K063306", "K063400", "K896830", "K991850", "K983253", "K050178", "K110056", "K071132", "K173127", "K896582", "K820076", "K010748", "K110313", "K802233", "K051200", "K791642", "K852986", "K905513", "K934070", "K081269", "K920449", "K070452", "K874749", "K791135", "K936204", "K791777", "K993131", "K020234", "K931183", "K830935", "K904027", "K091400", "K060001", "K151809", "K120497", "K991246", "K901414", "K033847", "K810714", "K822977", "K881863", "K833805", "K991483", "K133803", "K113437", "K000885", "K930823", "K791365", "K140827", "K071466", "K141944", "K955087", "K141750", "K790046", "K023763", "K090413", "K875354", "K031539", "K992085", "K073309", "K973696", "K000887", "K862556", "K821360", "K880673", "K192369", "K013465", "K833772", "K854010", "K100547", "K100304", "K802432", "K801561", "K781851", "K042193", "K801289", "K936285", "K921831", "K011933", "K041764", "K080618", "K896334", "K001392", "K111128", "K031296", "K822867", "K911625", "K110188", "K040872", "K974491", "K121842", "K902455", "K862371", "K810638", "K872852", "K961674", "K921676", "K130990", "K896335", "K880698", "K020532", "K800794", "K041635", "K140829", "K802832", "K921305", "K020235", "K102045", "K231465", "K093548", "K864643", "K904814", "K021484", "K052464", "K983172", "K882222", "K833356", "K131307", "K820279", "K831837", "K791428", "K933287", "K984268", "K884315", "K091711", "K891235", "K893453", "K063209", "K940143", "K181915", "K920198", "K812242", "K072686", "K160762", "K012410", "K860572", "K926469", "K051321", "K973365", "K913614", "K946274", "K120199", "K012525", "K810958", "K803186", "K993590", "K831478", "K031042", "K090699", "K873428", "K082275", "K112015", "K162281", "K851636", "K214117", "K990899", "K003120", "K121366", "K161533", "K170623", "K070734", "K920820", "K142664", "K925204", "K170147", "K000239", "K792086", "K171650", "K081895", "K062658", "K063643", "K183230", "K861697", "K180509", "K133344", "K011434", "K963844", "K122101", "K994045", "K905709", "K163633", "K142789", "K832087", "K980888", "K041444", "K221326", "K102914", "K031380", "K790583", "K852111", "K893224", "K902457" ], "device_name": "Assay, Glycosylated Hemoglobin", "medical_specialty_description": "Hematology", "regulation_number": "864.7470", "device_class": "2", "registration_number": [ "2027969", "2432235", "8031673", "1219029", "3043149833", "1220972", "9610633", "2050012", "8023060", "3005529799", "2032900", "3013660430", "1827821", "1931251", "3011061417", "3002809144", "8043889", "2084025", "3006198300", "8023024", "2915274", "1616487", "3002637618", "3004111573", "3003539867", "3014607865", "9610126", "3007662974", "2085064", "3009448641", "1181121", "9613069", "3035708936", "3012526002", "9680746", "3015525148", "3004145393", "3023162659", "2517506", "3004529019", "3017548799", "2247288", "3016438761", "3005146313", "3003460426", "3032069621", "1832216", "3023949424", "3003422726", "3005333358", "2050010", "1423455", "1717966", "3008178161", "2030861", "9611444", "8020316", "9610529", "3003917514", "3004493545", "3010825766", "3003795116", "1832816", "3043654757", "3006421415", "1000487132" ], "fei_number": [ "3003992026", "2432235", "1219029", "3043149833", "3002806559", "1220972", "1000206808", "3002806809", "2050012", "3005529799", "2084025", "3013660430", "1827821", "1931251", "3011061417", "3002809144", "3006198300", "3000215862", "6387", "2915274", "3003045237", "3002637618", "1616487", "3004111573", "3014607865", "3007662974", "3002806560", "3009448641", "1000135102", "1181121", "3035708936", "3012526002", "3004145393", "3000206414", "3023162659", "3004445302", "2517506", "3002806693", "3017548799", "3004529019", "3016438761", "3005146313", "3003460426", "3002698769", "3032069621", "1832216", "3003206796", "3023949424", "3003422726", "1000122044", "2967", "3005333358", "1000125596", "2050010", "1717966", "3008178161", "3004493545", "3006769061", "3003917514", "3010825766", "3003795116", "1832816", "3002807423", "3043654757", "3006421415", "1000487132" ] } } ] }