{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "83881",
      "product_res_number": "Z-0813-2010",
      "event_date_initiated": "2009-08-18",
      "event_date_posted": "2010-02-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-05-18",
      "res_event_number": "52754",
      "product_code": "JBP",
      "k_numbers": [
        "K992571"
      ],
      "product_description": "Abbott i-STAT ACT Celite Cartridges.\n\nIn vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples.",
      "code_info": "Catalog number: 07G01-1",
      "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": "Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded. The Cartridge Test Information sheets that it should be 2 mL of blood - which is incorrect.",
      "root_cause_description": "Labeling False and Misleading",
      "action": "Abbott Point of Care issued an \"Important Product Information\" letter beginning August 18, 2009.  Consignees were instructed on how to reconcile all affected product.\n\nFor further information, contact Abbott Point of Care Technical Support at 1-800-366-8020, Option 1.",
      "product_quantity": "696,675 Cartridges",
      "distribution_pattern": "Worldwide distribution.",
      "openfda": {
        "k_number": [
          "K983649",
          "K984141",
          "K062604",
          "K913861",
          "K964609",
          "K860122",
          "K023582",
          "K960749",
          "K020914",
          "K902081",
          "K002528",
          "K790346",
          "K854686",
          "K013078",
          "K832189",
          "K992851",
          "K941007",
          "K923594",
          "K843459",
          "K992571",
          "K994194",
          "K971935",
          "K032952",
          "K223635"
        ],
        "device_name": "Activated Whole Blood Clotting Time",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7140",
        "device_class": "2",
        "registration_number": [
          "1644474",
          "3006198300",
          "2245578",
          "1217183",
          "1719400",
          "1618982",
          "2184009",
          "3005643513",
          "1718389",
          "3019849102",
          "1219343",
          "3002721930",
          "1928237"
        ],
        "fei_number": [
          "3006198300",
          "2245578",
          "1217183",
          "1719400",
          "1618982",
          "3005643513",
          "1000116989",
          "1000116158",
          "3019849102",
          "1219343",
          "2250033",
          "1718389",
          "1928237"
        ]
      }
    }
  ]
}