{
  "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": "2026-08-05",
    "results": {
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    {
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      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
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      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "NURSE",
      "manufacturer_contact_plocal": "",
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      "manufacturer_contact_l_name": "",
      "source_type": [
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20120605",
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          "implant_flag": "",
          "date_removed_flag": "",
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          "generic_name": "REFER TO 510 (K)",
          "manufacturer_d_name": "BIO-RAD LABORATORIES",
          "manufacturer_d_address_1": "9500 JERONIMO RD.",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "IRVINE",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "92618",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "92618",
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          "openfda": {
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            "fei_number": [
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      "product_problems": [
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      "reporter_state_code": "OH",
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      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250811",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
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      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20110408",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "UNK",
          "patient_sex": "",
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          "patient_problems": [
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      ],
      "distributor_city": "",
      "date_report": "20110407",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "2089785",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20110401",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
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          "mdr_text_key": "15497018",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE LABELING AND CERTIFICATE OF ANALYSIS INDICATE THAT EACH HUMAN DONOR UNIT USED TO MFR THE PRODUCT WAS \"TESTED AND FOUND (B)(6) FOR (B)(6), ANTIBODY TO (B)(6), AND (B)(6).\" IN ADDITION, THE LABELING INSTRUCTS THE USERS TO TREAT ALL HUMAN SOURCE MATERIAL AS POTENTIALLY INFECTIOUS AND SHOULD BE HANDLED WITH THE SAME PRECAUTIONS USED WITH PT SPECIMENS. THE ROOT CAUSE OF THE EVENT WAS USER ERROR."
        },
        {
          "mdr_text_key": "14929643",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "A LABORATORY EMPLOYEE SPLASHED LYPOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL LEVEL 1 INTO HER EYES WHILE OPENING AN AMPOULE OF THE CONTROL."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}