{
  "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": "Indianapolis",
      "address_1": "7736 Zionsville Rd",
      "reason_for_recall": "During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the CardioChek PA meter for the creatinine assay.",
      "address_2": "",
      "product_quantity": "1650 vials",
      "code_info": "Cat No. 1720; and Lot number F103",
      "center_classification_date": "20120628",
      "distribution_pattern": "Worldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France.",
      "state": "IN",
      "product_description": "PTS Panels Creatinine test strips.    PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample",
      "report_date": "20120704",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Polymer Technology Systems, Inc.",
      "recall_number": "Z-1903-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "61966",
      "termination_date": "20120720",
      "more_code_info": "",
      "recall_initiation_date": "20120515",
      "postal_code": "46268-2175",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}