{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Richmond Hill",
      "state": "N/A",
      "country": "Canada",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91130",
      "recalling_firm": "Qvella Corporation",
      "address_1": "9133 Leslie St",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: CA, NY, AL, UT",
      "recall_number": "Z-0425-2023",
      "product_description": "The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacterial cells directly from a positive blood culture (PBC). The cartridge and instrument isolate and concentrate bacterial cells directly from PBC by removing blood, cellular and culture media matrix components from the sample, thereby reducing the sample volume considerably while maintaining bacterial cell viability. The resulting material is a purified microbial suspension or Liquid Colony for use in downstream in vitro diagnostics.",
      "product_quantity": "1868",
      "reason_for_recall": "Device exceeds the limitations of a Class I 510(k)-exempt device so the user manual, instructions for use, and promotional materials are being corrected to remove all references to downstream applications.",
      "recall_initiation_date": "20221102",
      "center_classification_date": "20221207",
      "report_date": "20221214",
      "code_info": "TSP-UM-001, Revisions: 2 and 3; MKT-0025, Revisions: 2 and 3;  TSP-PI-001, Revisions: 2 and 3"
    }
  ]
}