{
  "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": "93378",
      "recalling_firm": "Ortho-Clinical Diagnostics, INc.",
      "address_1": "513 Technology Blvd",
      "address_2": "",
      "postal_code": "14626-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide  Foreign: Bermuda  Canada",
      "recall_number": "Z-0510-2024",
      "product_description": "VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only.  VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600 XT 3400 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.  Product Code: 8262396",
      "product_quantity": "622 units  300 Slides (5 cartridge containing 60 slides)",
      "reason_for_recall": "Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which may contain consecutive slides that may not function as intended.  These affected slides (potentially intermittent, consecutive slides within a cart or across consecutive carts) have an abnormality which may cause positively or negatively biased total carbon dioxide (CO2) results leading to either overdiagnosis of acidosis or missing alkalosis, both which may prompt unnecessary therapies such as IV fluids and/or bicarbonate or overdiagnosis of alkalosis which may also result in unnecessary use of IV fluids and electrolyte replacement or failure to detect acidosis and necessary treatment.",
      "recall_initiation_date": "20231025",
      "center_classification_date": "20231207",
      "report_date": "20231213",
      "code_info": "UDI-DI: 10758750004645 Lot Numbers/Exp. Date: 5732-3598-4649   01-Feb-2025; 5732-3598-4650   01-Feb-2025; 5732-3598-4651   01-Feb-2025; 5732-3598-5102   01-Mar-2025; 5732-3598-5105   01-Mar-2025; 5732-3598-5189   01-Mar-2025",
      "more_code_info": ""
    }
  ]
}