{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "cfres_id": "189843",
      "product_res_number": "Z-0214-2022",
      "event_date_initiated": "2021-10-14",
      "event_date_posted": "2021-11-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2025-02-14",
      "res_event_number": "88869",
      "product_code": "KLI",
      "k_numbers": [
        "K991432"
      ],
      "product_description": "T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only\n\nThis product s intended use is  For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.",
      "code_info": "Lot # RN-60831 or RN-60923",
      "firm_fei_number": "3002564473",
      "recalling_firm": "BioCheck, Inc.",
      "address_1": "425 Eccles Ave",
      "city": "South San Francisco",
      "state": "CA",
      "postal_code": "94080-1902",
      "additional_info_contact": "Johanna Saito\n650-573-1968",
      "reason_for_recall": "Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.",
      "root_cause_description": "Component change control",
      "action": "On October 14, 2021 BioCheck issued a \"Medical Device Recall Notification\" to affected customers. In addition to informing consignees about the recall, BioCheck asked consignees to take the following actions:\n\n1) Please immediately discontinue use or distribution of the affected lots.\n\n2) If you have further distributed the affected product lots, please identify those\ncustomers and notify them at once of this product recall.\n\n3) If you have relabeled or rebranded the affected product lots, please follow your\ninternal recall process and notify appropriate regulatory bodies, if required.\n\n4) Disposal of all affected lots should be in accordance with applicable national, state,\nand local laws and regulations.\n\n5) Complete and return the enclosed Return Response Form by October 29, 2021 to BioCheck, Inc,, 425 Eccles Avenue, South San Francisco, CA 94080 or email to: jsaito@biocheckinc.com as is required to meet subsequent FDA Status Reporting requirements.\n\nCUSTOMER CREDIT\n8. Upon receipt of completed Return Response Form, customer's account will be credited for the identified products that are disposed of. \n\nIf you have any questions, contact Director QA/RA at (650) 573-1968 or email: jsaito@biocheckinc.com.",
      "product_quantity": "314 kits",
      "distribution_pattern": "US Distribution to states of: MI, FL, NJ, OH, CA; and OUS (foreign) distribution to countries of: Spain, Taiwan and Nigeria",
      "openfda": {
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        ],
        "registration_number": [
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        "device_name": "Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1700",
        "device_class": "2"
      }
    }
  ]
}