{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Rochester",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95904",
      "recalling_firm": "QUIDEL ORTHO",
      "address_1": "100 Indigo Creek Dr",
      "address_2": "",
      "postal_code": "14626-5101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Domestic: Nationwide Distribution  International: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom,",
      "recall_number": "Z-0902-2025",
      "product_description": "Brand Name: VITROS Chemistry Products  Product Name: VITROS Chemistry Products DGXN Slides  Model/Catalog Number: 8343386  Software Version: Not Applicable  Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support.      Digoxin 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.    VITROS 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.    One sales unit contains 5 cartridges.  Each cartridge holds 18 slides (equivalent to one test), for 90 slides per sales unit.  Component: No, not a component",
      "product_quantity": "1,541 units (1,125 US, 416 OUS)",
      "reason_for_recall": "Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.",
      "recall_initiation_date": "20241205",
      "center_classification_date": "20250110",
      "report_date": "20250122",
      "code_info": "Model No 8343386; UDI/GTIN 10758750004782;  Coating 0272, expiration date; 01-April-2025  The 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.",
      "more_code_info": ""
    }
  ]
}