{
  "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": "Terminated",
      "city": "Indianapolis",
      "state": "IN",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83097",
      "recalling_firm": "Polymer Technology Systems, Inc.",
      "address_1": "7736 Zionsville Rd",
      "address_2": "N/A",
      "postal_code": "46268-2175",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide    Bahamas  Belgium  Bermuda  Brazil  England  Indonesia  Latvia  Mexico  Nigeria  Puerto Rico  South Africa  Sweden  Taiwan",
      "recall_number": "Z-2157-2019",
      "product_description": "PTS Panels Lipid Panel test strip:  IVD Lipid Panel Test Strips  Ref Number: 1710      Product Usage:  PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip¿ is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.",
      "product_quantity": "1,887 vials US; 2,728 vials  OUS",
      "reason_for_recall": "The MEMo chips provided with lot P901 may be mislabeled,  the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901",
      "recall_initiation_date": "20190607",
      "center_classification_date": "20190805",
      "termination_date": "20200708",
      "report_date": "20190814",
      "code_info": "Lot Number: P901   Exp. Date:  8/17/2020  (01) 00381931710016 (17) 200817 (10) P901"
    }
  ]
}