{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "90226",
      "product_res_number": "Z-0456-2011",
      "event_date_initiated": "2010-03-17",
      "event_date_posted": "2010-11-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-09-22",
      "res_event_number": "55178",
      "product_code": "CGL",
      "k_numbers": [
        "K973292"
      ],
      "product_description": "i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.",
      "code_info": "Lot numbers A09279A and A09280A, Exp March 2010",
      "firm_fei_number": "2245578",
      "recalling_firm": "Abbott Point of Care Inc.",
      "address_1": "400 College Rd E",
      "city": "Princeton",
      "state": "NJ",
      "postal_code": "08540-6607",
      "additional_info_contact": "Peter Scott\n609-454-9270",
      "reason_for_recall": "The i-STAT CREA Cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks.",
      "root_cause_description": "Other",
      "action": "Abbott Point of Care issued Urgent Product Recall Notification letters dated March 2010 to all direct customers identifying the affected product and the actions to be taken. Customers were instructed to determine if they had cartirdges that had been stored above 25 degrees Celsius, and if so, contact Abbott for replacement or credit. \nAbbott Technical Support can be contacted at 800-366-8020 option 1 about this recall.",
      "product_quantity": "34525 cartridges",
      "distribution_pattern": "Worldwide Distribution: Throughout USA and Canada.",
      "openfda": {
        "k_number": [
          "K261039",
          "K070068",
          "K973292",
          "K991727",
          "K051968",
          "K113726",
          "K171059",
          "K903034"
        ],
        "device_name": "Electrode, Ion Based, Enzymatic, Creatinine",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1225",
        "device_class": "2",
        "registration_number": [
          "3005643513",
          "3012817228",
          "2245578",
          "1219029",
          "3013513377",
          "3023162659",
          "3002807968",
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        ],
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      }
    }
  ]
}