{
  "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": "2026-08-12",
    "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": "99128",
      "recalling_firm": "Instrumentation Laboratory",
      "address_1": "180 Hartwell Rd",
      "address_2": "",
      "postal_code": "01730-2443",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy.",
      "recall_number": "Z-2899-2026",
      "product_description": "GEM Premier 7000 with iQM3    Part Numbers:     00077407508  00077407510  00077415004  00077415008  00077415010  00077430010    Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.",
      "product_quantity": "32 units",
      "reason_for_recall": "The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.",
      "recall_initiation_date": "20260521",
      "center_classification_date": "20260806",
      "report_date": "20260812",
      "code_info": "Part No.00077407508 UDI-DI 00195226000764 Lot 260504E;  Part No. 00077407510 UDI-DI 00195226000665 Lot 260505B;  Part No. 00077415004 UDI-DI 00195226000856 Lot 260505A;  Part No. 00077415008 UDI-DI 00195226000757 Lot No.260505A;  Part No. 00077415010 UDI-DI 00195226000658 Lot 260505C;  Part No. 00077430010 UDI-DI 00195226000641 Lot 260505B",
      "more_code_info": ""
    }
  ]
}