{ "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": 39 } }, "results": [ { "cfres_id": "167677", "product_res_number": "Z-0301-2019", "event_date_initiated": "2018-09-24", "event_date_created": "2018-10-31", "recall_status": "Terminated", "event_date_terminated": "2022-02-09", "res_event_number": "81177", "product_code": "KHE", "k_numbers": [ "K033548" ], "product_description": "Roche Diagnostics URISYS 1100 Urine Analyzer\nPart Number: 03617556001\n\nProduct Usage:\nThe URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA urine test strips for various urine analytes.: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood", "code_info": "All serial numbers", "firm_fei_number": "1823260", "recalling_firm": "Roche Diagnostics Corporation", "address_1": "9115 Hague Rd", "city": "Indianapolis", "state": "IN", "postal_code": "46256-1025", "additional_info_contact": "Roche Customer Support Center\n800-428-2336", "reason_for_recall": "Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the Urisys 1100 urine analyzer with Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA test strips were higher than what is listed in the test strip method sheets may lead to false negative results for the affected parameters", "root_cause_description": "Under Investigation by firm", "action": "Roche Diagnostics notified Consignees by the Urgent Medical Device Correction (UMDC) sent UPS Ground (receipt required) on 9/24/18. For consignees associated only with a PO number address, the UMDC will be sent by USPS mail.\nConsignee Instructions:\n1. When using Chemstrip 5 Ob and/or Chemstrip 7 test strips, results should\nonly be read visually.\n These test strips can no longer be read on the Urisys 1100 urine analyzer.\n Follow the directions in the Instructions for Manually Reading Chemstrip test Strip results section of the UMDC.\n2. When using Chemistrip 10 MD or Chemstrip 10 UA test strips:\n You can choose to read the test strips visually or\n If you continue to use the strips with the Urisys 1100 urine analyzer, a\nnegative result for any of the four affected parameters (protein, nitrite,\nleukocytes, and erythrocytes) must be repeated with a new test strip\nthat is read visually. Follow the directions in the instructions for\nManually Reading Chemstrip Test Strip Results section of the UMDC.\n3. If you are unable to implement the visual read-only method for\nChemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, or Chemstrip 10 UA test\nstrips:\n Dispose of the affected test strip vials per local guidelines.\n Contact your distributor partner for credit.\n4. Complete all sections of the enclosed fax back forms\nContact Roche Diagnostics Point-of-Care Technical Service, 24 hours a day, seven days a week at 1-800-428-4674 if you have questions", "product_quantity": "14,398 units", "distribution_pattern": "US Nationwide Distribution", "openfda": { "k_number": [ "K854358", "K031356", "K812428", "K833369", "K830223", "K874180", "K984269", "K761232", "K052598", "K812728", "K843352", "K163554", "K813204", "K003359", "K021423", "K041202", "K832864", "K980671", "K834297", "K030216", "K981661", "K811752", "K162333", "K143325", "K834456", "K882799", "K911075", "K173212", "K840903", "K871143", "K972763", "K842137", "K121397", "K832311", "K800433", "K811815", "K002930", "K820072", "K961062", "K873409", "K921798", "K171484", "K770153", "K840527", "K936056", "K840904", "K896474", "K022755", "K102664", "K901064", "K830919", "K881907", "K822731", "K843601", "K002756", "K061065", "K070660", "K862849", "K902360", "K073431", "K860028", "K905798", "K060953", "K874482", "K880499", "K100817", "K992759", "K853141", "K861731", "K002457", "K913622", "K810488", "K080812", "K113506", "K110309", "K051806", "K905782", "K060930", "K912979", "K780214", "K041297", "K883432", "K843532", "K071242", "K884206", "K100031", "K780564", "K063673", "K821884", "K855237", "K854619", "K060463", "K792655", "K063693", "K850431", "K170548", "K033548" ], "registration_number": [ "", "3042471840", "3008517993", "1616487", "3043196750", "3004635103", "3023322455", "3005610352", "2250030", "9710094", "2030538", "2410251", "3004569406", "3017231634", "1226769", "3003917514", "2050010", "1123776", "3009238284", "3005360469", "2087033", "3021186226", "2029372", "2014676", "2025099", "3007301207", "3012516456", "2024674", "2435505", "1649661", "1000369487", "9610126", "3016609999", "3030708766", "3015751263", "2060833", "3033751096", "3033507883", "3024753119", "2032839", "3005345870", "3011945100", "3005984081", "3021090658", "2246703", "1832216", "9611917", "1518939", "3025041446", "3002637618", "3005174594", "1061932", "1417592", "2030633", "1017835", "3007606081", "3002792284", "3011287770", "2244821", "3005311019", "3022178699", "1618982", "3006621318" ], "fei_number": [ "", "3004185580", "3003224146", "3042471840", "3008517993", "1616487", "3005670738", "3043196750", "3004635103", "3023322455", "2250030", "1000520007", "2410251", "3004569406", "3017231634", "3003917514", "2050010", "3009238284", "1000219815", "3000203293", "3021186226", "2014676", "3007301207", "3012516456", "2024674", "1000369487", "3003347234", "3016609999", "1000119795", "3001452245", "3030708766", "3015751263", "3002806884", "3007981058", "3002806559", "3033507883", "3033751096", "3009431614", "1000306617", "3024753119", "3005345870", "3011945100", "3005984081", "3021090658", "2246703", "3000210620", "1832216", "1518939", "3025041446", "3002637618", "3005174594", "1017835", "1417592", "3003102569", "3007606081", "3002792284", "3011287770", "2244821", "3005311019", "3001451797", "3022178699", "1618982", "3006621318" ], "device_name": "Reagent, Occult Blood", "medical_specialty_description": "Hematology", "regulation_number": "864.6550", "device_class": "2" } } ] }