{ "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": "95485", "product_res_number": "Z-0577-2011", "event_date_initiated": "2010-10-01", "event_date_posted": "2010-12-09", "recall_status": "Terminated", "event_date_terminated": "2012-08-03", "res_event_number": "57157", "product_code": "KQO", "product_description": "Teco Diagnostics Uritek TC-101 Urine Analyzer, Catalog Number: TC-101 \nThe Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.", "code_info": "All units sold (2005 - 2010)", "firm_fei_number": "1832216", "recalling_firm": "Teco Diagnostics", "address_1": "1268 N Lakeview Ave", "city": "Anaheim", "state": "CA", "postal_code": "92807-1831", "additional_info_contact": "714-463-1111", "reason_for_recall": "This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by\nthe FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di", "root_cause_description": "Other", "action": "Teco Diagnostics initiated an \"Urgent: Medical Device Recall\" letter dated October 14, 2010, with an attached \"Recall Return Response Form\" to the affected consignees via US Postal on October 15, 2010. The recall notice informed the consignees of the reason for recall, the products affected and the actions required.\n\nConsignees were instructed to complete and return the enclosed Recall Return Response Form as soon as possible via mail, fax, or email. Upon receipt of the Recall Return Response\nForm, Teco Diagnostics would work with the consignees/distributors to process any refunds or reimbursements for the returned product and return shipping. If consignees/distributor had questions, they were to call Teco's Technical Support Department at (800) 222-9880 or (714) 463-1111.", "product_quantity": "2,140 units total for all products", "distribution_pattern": "Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, AND WV and the country of Canada.", "openfda": { "k_number": [ "K031947", "K954158", "K842238", "K954156", "K051526", "K934042", "K761306", "K943463", "K053253", "K921087", "K121456", "K960546", "K760472", "K101852", "K926359", "K030600", "K932674", "K931602", "K012829", "K972141", "K013783", "K935408", "K102188", "K093098", "K813056", "K954024", "K870526", "K951877", "K830220", "K093555", "K841041", "K091472", "K140717", "K954514", "K840996", "K142543", "K980047", "K842237", "K042421", "K983510", "K821738", "K943592", "K946183", "K070929", "K960054", "K141874" ], "registration_number": [ "", "3043138885", "3038206980", "3027645317", "1649661", "2432235", "3020704087", "3013188547", "9610633", "3005146144", "3014150341", "3005360469", "3012494290", "3018771894", "2030633", "2531491", "3013660430", "3024463179", "3006479639", "3006198300", "3007301207", "1417592", "3015341499", "3043088937", "1616487", "3002637618", "3043226252", "3031915160", "2029372", "3034731501", "1036362", "3038188172", "9610126", "3033509895", "3042471840", "2122870", "3009238284", "3009448641", "1181121", "3006621318", "9615507", "9680746", "3043127699", "3003741796", "1061932", "3010564249", "1000369487", "3015921024", "1832216", "4580", "3008517993", "3010891909", "3010324880", "3027225088", "3003422726", "9710094", "3008058135", "9611444", "3006979678", "3003917514", "3008987086", "3004875840", "3003795116", "1832816", "3013679502" ], "fei_number": [ "", "3043138885", "3038206980", "3027645317", "2432235", "3005670738", "3002806559", "3013188547", "3020704087", "3014150341", "3005146144", "1000206808", "3000203293", "3012494290", "3018771894", "3003516723", "3024463179", "3013660430", "1000306617", "3006479639", "3006198300", "3007301207", "1417592", "3015341499", "3043088937", "3001451797", "1616487", "3002637618", "3043226252", "3031915160", "3034731501", "1036362", "3038188172", "3042471840", "3033509895", "2122870", "3009238284", "3009448641", "1181121", "3006621318", "3002829675", "3000210620", "3043127699", "3003741796", "3002806693", "3010564249", "1000369487", "3015921024", "1832216", "4580", "3008517993", "3010891909", "3010324880", "3003347234", "3027225088", "3003422726", "3008058135", "3006979678", "3003917514", "3008987086", "3004875840", "3003795116", "1832816", "3002807423", "3013679502" ], "device_name": "Automated Urinalysis System", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2900", "device_class": "1" } } ] }