{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "95163",
      "product_res_number": "Z-0400-2011",
      "event_date_initiated": "2010-10-06",
      "event_date_posted": "2010-11-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-08-22",
      "res_event_number": "57005",
      "product_code": "JBP",
      "k_numbers": [
        "K023582"
      ],
      "product_description": "i-STAT ACT Kaolin Cartridges\nin vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.",
      "code_info": "List numbers: 07G81-01, 07G81-02; Lot numbers: S10129, S10129A, S10130, S10130B, S10147A, S10147B, S10147C, S10147D, S10147E, S10148A, S10148B, S10148C, S10148D, S10148G, S10149, S10149B, S10149C, S10151A, S10151B, S10152, S10152A, S10152B, S10152C, S10152D,  S10152E, S10152F, S10154A, S10154B, S10154D, S10160B, S10162.",
      "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 J Scott\n609-454-9270",
      "reason_for_recall": "Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge.",
      "root_cause_description": "Other",
      "action": "Abbott Point of Care, Inc. sent an URGENT RECALL NOTICE dated September 2010 on October 6, 2010 by Federal Express to all US customers.  The letter identified the product, the problem, and the action to be taken by the customer.  \nCustomers were instructed to discontinue use of cartridges from the identified lots. If customers did not currently have replacement cartridges then they should continue to use the cartridge lot until their facility receives replacement material.\nUpon receipt of replacement material, customers were to discontinue use of and return the affected cartridges and switch to the replacement material. All unused cartridges will be credited and will be returned.\nIf you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point of Care representative.",
      "product_quantity": "95,325 cartridges",
      "distribution_pattern": "Worldwide Distribution",
      "openfda": {
        "k_number": [
          "K020914",
          "K902081",
          "K992851",
          "K984141",
          "K223635",
          "K062604",
          "K832189",
          "K923594",
          "K032952",
          "K843459",
          "K013078",
          "K002528",
          "K941007",
          "K023582",
          "K790346",
          "K994194",
          "K992571",
          "K964609",
          "K860122",
          "K971935",
          "K854686",
          "K960749",
          "K983649",
          "K913861"
        ],
        "device_name": "Activated Whole Blood Clotting Time",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7140",
        "device_class": "2",
        "registration_number": [
          "1718389",
          "3005643513",
          "3019849102",
          "1719400",
          "1928237",
          "2184009",
          "1618982",
          "1644474",
          "3006198300",
          "1217183",
          "2245578",
          "1219343",
          "3002721930"
        ],
        "fei_number": [
          "1718389",
          "3005643513",
          "3019849102",
          "2250033",
          "1000116989",
          "1928237",
          "1618982",
          "1000116158",
          "3006198300",
          "1217183",
          "2245578",
          "1219343",
          "1719400"
        ]
      }
    }
  ]
}