{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "195319",
      "product_res_number": "Z-1641-2022",
      "event_date_initiated": "2022-07-07",
      "event_date_created": "2022-08-26",
      "recall_status": "Open, Classified",
      "res_event_number": "90654",
      "product_code": "OJN",
      "product_description": "T-SPOT.TB REF TB.300 US",
      "code_info": "Model/Catalog Number: TB.300 US\nUDI-DI Code: 15051716000305\nLot Number: TEC4000098",
      "firm_fei_number": "3015492990",
      "recalling_firm": "OXFORD IMMUNOTEC LTD",
      "address_1": "143 Park Road",
      "city": "Abingdon",
      "country": "United Kingdom",
      "reason_for_recall": "Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.",
      "root_cause_description": "Storage",
      "action": "On 07/07/2022, Oxford Immunotec Limited send a Field Safety Notice to customers informing them that the firm has become aware that products distributed may have been stored outside of the storage specifications for a short period.  Customer are asked to quarantined the affected products until further notice.\n\nOn 07/13/2022, the firm communicated a follow-up \"URGENT ACTION REQUIRED\" Letter to customer asking to confirm that affected products have been segregated into a quarantine area and have not been used to produce patient results.\n\nOn 07/20/2022, the firm sent a \"VOLUNTARY PRODUCT RECALL NOTIFICATION\" informing customers that Oxford Immunotec Limited is conducting a full recall of the affected products and asking customers to now destroy the affected products following these steps:\n1. Ensure Recalled Product remains in Quarantine. As per our previous\ncommunication dated July-13-2022, please ensure all stock of the above\nproducts remain in a secure location pending destruction.\n2. Complete Tracking/Verification Form. Complete and return the enclosed\ntracking/verification form, following the directions on this page and the\nTracking/Verification Form. Your Oxford Immunotec sales representative\ncan assist you in completing the form.\n3. Indicate Destroyed Products on Tracking/Verification Form. The\ntracking/verification form lists the [product name] and product descriptions.\nPlease mark the number of each type of [product] that you are destroying on\nthis form.\n\nOn or after 08/03/2022, Oxford Immunotec Ltd communicated an updated/follow-up customer notification with included the potential risks/harms/hazards associated with the use of the affected products.\n\nFor questions or assistance - contact Chris Dark at +44 1235 442780 or Maureen Garner at 855-NWRS-222 (855-697-7222), or alternatively any Oxford Immunotec Sales Representatives.",
      "product_quantity": "81 units",
      "distribution_pattern": "U.S.: AL, CA, DC, GA, IN, OR, and WA\n\nO.U.S.: None",
      "openfda": {
        "pma_number": [
          "P070006"
        ],
        "device_name": "Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3015492990"
        ],
        "fei_number": [
          "3015492990"
        ]
      }
    }
  ]
}