{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192093",
      "product_res_number": "Z-0731-2022",
      "event_date_initiated": "2022-02-25",
      "event_date_posted": "2022-03-08",
      "recall_status": "Open, Classified",
      "res_event_number": "89640",
      "product_code": "QKP",
      "product_description": "Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02",
      "code_info": "Lot Numbers: COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006, COVGCCM1007",
      "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": "Charlotte Jaeun Kang\n201-988-4615",
      "reason_for_recall": "Kits were labeled with incorrect expiration dates.",
      "root_cause_description": "Incorrect or no expiration date",
      "action": "An URGENT: MEDICAL DEVICE RECALL notification letter dated 2/25/22 was sent to customers.\n\nImmediate Actions to be taken by You:\n1. Examine your inventory for affected product. Please identify the LOT number printed on the outer box to determine whether the products you received are from lots COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006 or COVGCCM1007.\n2. If you identify kits from the lots above in your inventory, quarantine the products and do not use them.\n3. If you identified kits with Lot Number COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006 or COVGCCM1007, please contact celltrionusa.CS@celltrion.com and Celltrion USA, Inc. will provide the shipping label for return to the address below.\nCelltrion USA, Inc.\nOne Evertrust Plaza Suite 1207, \nJersey City, New Jersey, 07302, USA\n4. Please complete the enclosed Acknowledgement and Receipt Form with the information requested and return the form in accordance with the instructions on the form. Please complete this form even if you do not have the product on hand.\nFor additional questions, please contact Celltrion USA by calling +1 (201) 320-2023 Monday through Friday, 9:00 AM to 6:00 PM or email to celltrionusa.CS@celltrion.com.",
      "product_quantity": "1,228,200 tests",
      "distribution_pattern": "The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and TX.",
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        "device_name": "Coronavirus Antigen Detection Test System.",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
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    }
  ]
}