{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Houston",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90588",
      "recalling_firm": "Aggredyne, Inc.",
      "address_1": "10530 Rockley Rd Ste 150",
      "address_2": "",
      "postal_code": "77099-3574",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "International distribution to the country of South Korea.",
      "recall_number": "Z-1639-2022",
      "product_description": "AggreGuide A-100 Instrument",
      "product_quantity": "47",
      "reason_for_recall": "The firm identified a software design issue where the improper shut down of the instrument resulted in \u001cspeeds.csv\u001d file contents of the software version 5.1 being erased. Due to this issue, the target RPM for the assay is \u001c0\u001d and the motor output required to achieve this RPM is also \u001c0\u001d. Therefore, when the assay is run, the software applies 0 Volts to the motor and performs a 0 RPM assay. Because of this, there is no mixing of the blood with agonist and no moving of aggregates happens in front of the optical detectors. The resulting PAI is 0 and the result is displayed as \u001cLow\u001d.",
      "recall_initiation_date": "20190723",
      "center_classification_date": "20220826",
      "report_date": "20220907",
      "code_info": "UDI-DI: 00856893004065; Software Versions 5.1 or 5.2; Serial Numbers Between xx0001 and xx0160",
      "more_code_info": ""
    }
  ]
}