{
  "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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      "product_res_number": "Z-0558-2022",
      "event_date_initiated": "2021-12-01",
      "event_date_created": "2022-02-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-06-17",
      "res_event_number": "89455",
      "product_code": "QKP",
      "product_description": "Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.",
      "code_info": "All lots",
      "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": "The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.",
      "root_cause_description": "No Marketing Application",
      "action": "Celltrion Healthcare informs Celltrion USA on 2021-11-11 that it had sent cease and desist letter to distributors who were illegally distributing non-EUA product in the U.S. Celltrion demanded return of all EU product from distributors' inventory and demanded removal of all EU DiaTrustTests from the U.S. \n\nIn addition, the firm sent letters to all EU distributors warning against diversion and obtaining confirmation that distributors understand limitations on distribution only within the EU.",
      "product_quantity": "162,000 ea",
      "distribution_pattern": "US Nationwide distribution in the state of CA.",
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        "medical_specialty_description": "Unknown",
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        "device_class": "N"
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  ]
}