{
  "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": "2026-08-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bedford",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99115",
      "recalling_firm": "Instrumentation Laboratory",
      "address_1": "180 Hartwell Rd",
      "address_2": "N/A",
      "postal_code": "01730-2443",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-2822-2026",
      "product_description": "Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279  Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer",
      "product_quantity": "4 US",
      "reason_for_recall": "Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.",
      "recall_initiation_date": "20260508",
      "center_classification_date": "20260729",
      "report_date": "20260805",
      "code_info": "GEM Premier 7000: Part number: 00000015279 UDI: 0195226000924 Units distributed in US:    GEM Premier 7000 Serial Nos. 26012062, 26012065, 26012069 and 26012070.  Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026.  Part No. 00024015859; UDI No. 08426950869634"
    }
  ]
}