{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85346",
      "recalling_firm": "Hologic, Inc",
      "address_1": "10210 Genetic Center Dr",
      "address_2": "N/A",
      "postal_code": "92121-4362",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US:  AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, VI, WA, WI   OUS:  AU, CA",
      "recall_number": "Z-2163-2020",
      "product_description": "Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution  and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214",
      "product_quantity": "47 kits",
      "reason_for_recall": "Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.",
      "recall_initiation_date": "20191010",
      "center_classification_date": "20200528",
      "report_date": "20200603",
      "code_info": "Panther Fusion Extraction Reagent-S Lot number: 258402  Panther Fusion Capture Reagent-S Lot number: 257472  Panther Fusion Enhancer Reagent-S Lot number: 257473"
    }
  ]
}