{ "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": "211493", "product_res_number": "Z-0901-2025", "event_date_initiated": "2024-12-05", "event_date_posted": "2025-01-10", "recall_status": "Open, Classified", "res_event_number": "95904", "product_code": "LFM", "k_numbers": [ "K942610" ], "product_description": "Brand Name: VITROS Chemistry Products\nProduct Name: VITROS Chemistry Products DGXN Slides\nModel/Catalog Number: 8343386\nSoftware Version: Not Applicable\nProduct Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. \n\nDigoxin is a widely prescribed cardiac glycoside indicated in the treatment of congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose.\n\nVITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.\n\nOne sales unit contains 5 cartridges. Each cartridge holds 18 slides (equivalent to one test), for 90 slides per sales unit.\nComponent: No, not a component", "code_info": "Model No 8343386; UDI/GTIN 10758750004782; \nCoating 0271, expiration date; 01-March-2025\n\nThe scope of this recall is limited to consignees who received VITROS Chemistry Products DGXN slides in the last 18 months. This will include in-date lots manufactured from coatings (production formulation) 0271 and/or 0272. Of the in date product, the latest expiration date is listed for the coating.", "firm_fei_number": "3032012487", "recalling_firm": "QUIDEL ORTHO", "address_1": "100 Indigo Creek Dr", "city": "Rochester", "state": "NY", "postal_code": "14626-5101", "additional_info_contact": "Joe Falvo\n585-4533452", "reason_for_recall": "Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.", "root_cause_description": "Device Design", "action": "On December 5, 2024 URGENT PRODUCT CORRECTION NOTIFICATION letters were sent to consignees. REQUIRED ACTIONS\n- For customers who have VITROS 5,1 FS/4600/5600/XT 3400/XT 7600 Systems: Load ADD DRV 6308 upon receipt.\n- For customers who have VITROS 250/350 Systems: Please be aware of the lowering of the Interferent Concentration limit from 300 mg/dL to 100 mg/dL at a digoxin concentration of 2.0 ng/mL (2.6 nmol/L).\n- Complete and return the enclosed Confirmation of Receipt form no later than December 13, 2024.\n- Save this notification with your User Documentation or post this notification by each VITROS 250/350/5,1 FS/4600/5600/XT 3400/XT 7600 System in your laboratory until the issue has been resolved.\n- Please forward this notification if the affected product was distributed outside of your facility. - If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Global Services Organization. Resolution\nOur investigation to revise the limit at which hemoglobin interference may reach an unacceptable level is ongoing. In the interim we will be issuing a Technical Bulletin to implement the temporary changes to the Sample Indices Threshold default hemolysis limit on the ADD and the hemoglobin Interferent Concentration limit for digoxin listed in the IFU. We will communicate again after our investigation has completed. QuidelOrtho is targeting to have an update by Q1 2025.\nContact Information\nWe apologize for the inconvenience this may cause your laboratory. If you have further questions, please contact our Global Services Organization at 1-800-421-3311. To report adverse events, contact your local Global Services Organization. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm, 1-800-332-1088.\n\nOn December 5, 2024 URGENT PRODUCT CORRECTION NOTIFICATION lette", "product_quantity": "4,417 units (3,358 US, 1,125 OUS)", "distribution_pattern": "Domestic: Nationwide Distribution\n\nInternational: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom,", "openfda": { "k_number": [ "K842578", "K970546", "K012112", "K891094", "K963158", "K862067", "K943235", "K913187", "K942610", "K990251", "K913240", "K842280", "K896021", "K942619", "K062024", "K900013", "K954420", "K830035", "K951631", "K915465" ], "registration_number": [ "1219913", "3000308930", "2432235", "1319681", "1319809", "1036362", "3012963943", "3004493545", "2517506", "9610126", "3002806944", "3010825766", "3010939897", "3002642396", "2250051", "8020888", "3006198300" ], "fei_number": [ "1219913", "3000308930", "2432235", "3002806559", "1000136573", "1036362", "3012963943", "3007019572", "2517506", "3004493545", "3002806944", "3010825766", "3010939897", "3002642396", "2250051", "1000305840", "3006198300" ], "device_name": "Enzyme Immunoassay, Digitoxin", "medical_specialty_description": "Clinical Toxicology", "regulation_number": "862.3300", "device_class": "2" } } ] }