{
  "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": "191796",
      "product_res_number": "Z-0659-2022",
      "event_date_initiated": "2021-12-28",
      "event_date_posted": "2022-03-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-06-10",
      "res_event_number": "89508",
      "product_code": "QKP",
      "product_description": "Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02",
      "code_info": "Lot COVGCCM0008",
      "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",
      "additional_info_contact": "Dennis Seungryum Kim\n551-655-9338",
      "reason_for_recall": "The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.",
      "root_cause_description": "Process control",
      "action": "The firm initially placed a hold on product due to complaints of false positive and false negative results in September 2021. After product was erroneously distributed from this lot in December 2021, the firm notified affected customers that the lot should not have been distributed and should not be used. This email went out on or around December 28, 2021.\n\nCustomers were instructed to NOT use the affected lot.",
      "product_quantity": "243 kits (6,075 tests)",
      "distribution_pattern": "US distribution to CA, FL, NJ, NY, PA, SC.",
      "openfda": {
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        "device_name": "Coronavirus Antigen Detection Test System.",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}