{
  "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": {
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      "event_date_initiated": "2021-12-02",
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      "recall_status": "Terminated",
      "event_date_terminated": "2024-06-10",
      "res_event_number": "89516",
      "product_code": "QKP",
      "product_description": "Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02",
      "code_info": "Lots COVGCCF0001, COVGCCF0002",
      "firm_fei_number": "3015423092",
      "recalling_firm": "CELLTRION USA INC",
      "address_1": "1 Evertrust Plz Ste 1207 1 Evertrust Plz",
      "address_2": "Ste 1207",
      "city": "Jersey City",
      "state": "NJ",
      "postal_code": "07302-3087",
      "reason_for_recall": "Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.",
      "root_cause_description": "Employee error",
      "action": "On December 2, 2021, the firm notified the affected distributor that the two lots are Research Use Only and should not be used. The distributor then notified the customer. Customer reported all product had been used.",
      "product_quantity": "8080 kits originally distributed; 726 kits redistributed",
      "distribution_pattern": "Distributed to TX.",
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        "medical_specialty_description": "Unknown",
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        "device_class": "N"
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