{
  "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-2900-2026",
      "product_description": "GEM Premier 5000 PAK    Part Numbers:     00055360010  00055360011  00055407504  00055415010  00055430010  00055430011  00055445010  00055445011  00055360010.A",
      "product_quantity": "109 units",
      "reason_for_recall": "The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 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. 00055360010 UDI-DI 08426950807599 Lots 260505K, 260504AG, 260505F;  Part No. 00055360011 UDI-DI 08426950807605 Lots 260505F and 260505J;  Part No. 00055407504 UDI-DI 08426950807537 Lot 260505R;  Part No. 00055415010 UDI-DI 08426950807698 Lots 260505H and 260505K;  Part No. 00055430010 UDI-DI 08426950807759 Lots 260505H, 260505K and 260505F;  Part No. 00055430011 UDI-DI 08426950807766 Lot 260505K;  Product No. 00055445010 UDI-DI 08426950807810 Lots 260504AA and 260505K;  Product No. 00055445011 UDI-DI 08426950807827 Lots 260505F and 260505J;  Product No. 00055360010.A UDI-DI 08426950807599 Lot 260504AF;",
      "more_code_info": ""
    }
  ]
}