{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Medley",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91723",
      "recalling_firm": "Entopsis , Inc.",
      "address_1": "7600 Nw 69th Ave",
      "address_2": "N/A",
      "postal_code": "33166-2521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide and  Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania",
      "recall_number": "Z-1299-2023",
      "product_description": "PCRopsis Reagent RVD with RVD Enhancer:   a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples",
      "product_quantity": "397 units",
      "reason_for_recall": "Presence of misleading label statements on the product label.",
      "recall_initiation_date": "20230221",
      "center_classification_date": "20230329",
      "report_date": "20230405",
      "code_info": "a) REF 78336001, Lot Numbers:  18, Exp. 05/2023; 20, Exp. 07/2023; 21, Exp. 07/2023;  b) REF 78336025, Lot Numbers:  18, Exp. 05/2023; 20, Exp. 07/2023; 21, Exp. 07/2023; c) REF 78336100, Lot Numbers:  21, Exp. 07/2023"
    }
  ]
}