{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Brea",
      "address_1": "250 S Kraemer Blvd",
      "reason_for_recall": "Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration with  error condition OCR LOW. The calibration failures appear to be related to improper shipping or  storage conditions (frozen reagent). Failed calibration of LACT may cause a delay in reporting results.",
      "address_2": "",
      "product_quantity": "3,353 units",
      "code_info": "Part Number A95550, Lot Number M210077",
      "center_classification_date": "20130627",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide and country of Canada.",
      "state": "CA",
      "product_description": "SYNCHRON System(s) Lactate (LACT) Reagent.    Product Usage:  Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s), UniCel¿ DxC 600/800 System(s) and Synchron¿ Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).",
      "report_date": "20130703",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Beckman Coulter Inc.",
      "recall_number": "Z-1613-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "65377",
      "termination_date": "20140603",
      "more_code_info": "",
      "recall_initiation_date": "20130528",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}