{
  "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-2821-2026",
      "product_description": "GEM Premier 5000 with IQM2  Model/Catalog Number: 00024019255 and  GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279   Portable blood analyzer system.    Affected Accessory:   Bar Code Reader (BCR) Wand Part No. 00024015859",
      "product_quantity": "122",
      "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 5000 Part number: 00024019255, UDI: 08426950870227   GEM Premier 7000 Part number: 00000015279, UDI: 0195226000924    Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634"
    }
  ]
}