{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Irvine",
      "address_1": "34 Bunsen",
      "reason_for_recall": "When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result of the microalbumin may be elevated more than 10%. This increase may affect serum, plasma and urine sample types.",
      "address_2": "",
      "product_quantity": "686 devices (233 devices US, 453 devices OUS)",
      "code_info": "All lot numbers; Software Version(s): Application versions below (V5.14 & V2.12) for Pentra 400 and Versions below (V1.07) for Pentra C400",
      "center_classification_date": "20180625",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and to countries of: Bulgaria, Burma, Cameroon,  Djibouti, France,  Gabon, Germany, Italy, Lebanon, Mali,   Mauritania, Poland, Portugal, Romania, Saudi Arabia, South Africa and Thailand.",
      "state": "CA",
      "product_description": "ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563      The device is intended for use in conjunction with certain materials to measure a variety of analytes.",
      "report_date": "20180704",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Horiba Instruments, Inc dba Horiba Medical",
      "recall_number": "Z-2286-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "80022",
      "termination_date": "20190926",
      "more_code_info": "",
      "recall_initiation_date": "20180426",
      "postal_code": "92618-4210",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}