{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "183650",
      "product_res_number": "Z-0103-2021",
      "event_date_initiated": "2020-08-27",
      "event_date_created": "2020-10-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-05-22",
      "res_event_number": "86406",
      "product_code": "DBI",
      "k_numbers": [
        "K012359"
      ],
      "product_description": "Tina-quant Complement C4 ver.2, Catalog 05991994190",
      "code_info": "lot 36870301",
      "firm_fei_number": "1823260",
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "address_1": "9115 Hague Rd",
      "city": "Indianapolis",
      "state": "IN",
      "postal_code": "46256-1025",
      "additional_info_contact": "Roche Customer Support\n800-428-2336",
      "reason_for_recall": "Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On August 27, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that this was an expansion of the previous notification sent on September 11, 2019, as new products and lots had been added to the scope of the recall.\n\nCustomers were asked to do the following:\n\n\" Discontinue use and discard any remaining affected product in your inventory according to your local waste\nguidelines.\n\" Refer to the Product Replacement section of the letter for product replacement information.\n\" Complete all sections of the enclosed fax back form and fax or email it according to the instructions on the form even if you are not requesting product replacement.\n\" If your facility has distributed the affected product to another site, please ensure this UMDC is provided to\nthat site.\n\" File this UMDC for future reference.\n\nRoche will replace any of the recalled product remaining in your inventory. To receive replacement product, please complete the response form enclosed with the firm's mailing and fax or email it according to the instructions on the form.\n\nPlease contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about this recall.",
      "product_quantity": "180 units",
      "distribution_pattern": "Domestic distribution nationwide.",
      "openfda": {
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          "K010325",
          "K831906",
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          "K882621",
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        ],
        "registration_number": [
          "2050012",
          "3004493545",
          "3019906",
          "3012963943",
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        "fei_number": [
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          "3010825766",
          "1000403749",
          "2432235",
          "1181121",
          "3000308930",
          "3006198300"
        ],
        "device_name": "Complement C4, Antigen, Antiserum, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5240",
        "device_class": "2"
      }
    }
  ]
}