{
  "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": "Canton",
      "address_1": "5449 Research Dr",
      "reason_for_recall": "Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport.  The crystals do not impact product performance.",
      "address_2": "",
      "product_quantity": "H7545-R1, 8.75 L; 12-H7545-162, 4 kits; H7545-1000, 3 kits; HDL600, 6 kits",
      "code_info": "Catalog numbers: H7545-R1, 12-H7545-162, H7545-1000, HDL600  Lot number: 430402",
      "center_classification_date": "20150916",
      "distribution_pattern": "Worldwide Distribution - US including MI, FL, CA, TX, CT, PR and Internationally to Canada.",
      "state": "MI",
      "product_description": "Pointe Scientific autoHDL Reagent H7545    H7545-R1 in a bulk cube container or HDPE plastic bottle  H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2  12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2  HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2    Kits:  HDPE plastic bottle, PP plastic caps.   Bulk:  PE plastic cube containers, PP plastic caps.    Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.",
      "report_date": "20150923",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Pointe Scientific, Inc.",
      "recall_number": "Z-2764-2015",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "71953",
      "termination_date": "20151029",
      "more_code_info": "",
      "recall_initiation_date": "20150313",
      "postal_code": "48188-2261",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}