{
  "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": "96870",
      "recalling_firm": "Ortho-Clinical Diagnostics, Inc.",
      "address_1": "100 Indigo Creek Dr",
      "address_2": "",
      "postal_code": "14626-5101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Please see the attached list \"Consignee List_CL2025-120.\"  Note: This file contains a specific tab, titled Shipping Summary, which contains the US and ex-US shipping summary.     One (1) Distributor was affected.  The other four(4) Distributors were sent the notification for information only.  QuidelOrtho sent the notification to their consignees because QuidelOrtho drop-shipped this product to their 31 consignees (Included in the Medical Facility total below).",
      "recall_number": "Z-1948-2025",
      "product_description": "Brand Name: Solana¿ Bordetella Complete Assay  Product Name: Solana Bordetella kit  Model/Catalog Number: M308  Software Version: not applicable  Product Description: One sales unit (kit) contains materials for 48 tests.    One kit contains 48 tubes of 1.45 mL Process Buffer and 48 Reaction Tubes.  Component: No, not a component",
      "product_quantity": "952 units",
      "reason_for_recall": "It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.",
      "recall_initiation_date": "20250324",
      "center_classification_date": "20250611",
      "report_date": "20250618",
      "code_info": "Lot Code: Catalog number: M308 UDI-DI: 30014613336167; Lots:  245251 - Exp. 2025-Oct-25 246941 - Exp. 2025-Dec-03 250163 - Exp. 2026-Feb-06 259686 - Exp. 2026-Sep-03 261072 - Exp. 2026-Oct-02 262113 - Exp. 2026-Oct-23 263331 - Exp. 2026-Nov-22 264065 - Exp. 2026-Dec-11 265007 - Exp. 2027-Jan-03 (corrected exp date from 2026-Dec-31) 266928 - Exp. 2026-Dec-31  Additional Lots: 265007-1 - Exp. 2026-Dec-31  268479 and above - Various Expiration dates  *Until further notice, all future lots, both supplied by QuidelOrtho or supplied by its distributors, will be affected.",
      "more_code_info": ""
    }
  ]
}