{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "115630",
      "product_res_number": "Z-0889-2013",
      "event_date_initiated": "2012-09-27",
      "event_date_posted": "2013-02-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-04-25",
      "res_event_number": "64228",
      "product_code": "NCD",
      "pma_numbers": [
        "P010033"
      ],
      "product_description": "Vacuette Cellestis 1 ml QuantiFERON TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total. \n\nProduct Usage:  QuantiFERON-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.",
      "code_info": "Cat # 0592-0501; Lot A111103M; Exp 28 FEB, 2013",
      "firm_fei_number": "3003964343",
      "recalling_firm": "Cellestis Inc",
      "address_1": "28358 Constellation Rd Ste 698 28358 Constellation Rd",
      "address_2": "Ste 698",
      "city": "Santa Clarita",
      "state": "CA",
      "postal_code": "91355-5044",
      "additional_info_contact": "Kevin Liddle, PhD\n661-775-7480",
      "reason_for_recall": "Cellestis is recalling QuantiFERON - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.",
      "root_cause_description": "Process design",
      "action": "Cellestis, inc., sent a \"Notification of market withdrawal of QuantiFERON\" letter dated September 27, 2012 to its domestic and international customers. The letter described the product, problem and actions to be taken. The customers were informed to discontinue use of these products and any product sequestered such that it cannot be used or distributed. Cellestis will provide replacement materials, if and when a retest is required.\n\nPlease do not hesitate to contact your local QuantiFERON sales representative or customer service representative at +613 8527 3500 or 661-775-7480 should you have any questions or concerns.",
      "product_quantity": "29,690 units",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Ireland, Israel, Jordan, Luxembourg, Mexico, Netherlands, New Zealand, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, South Africa, Switzerland, and Turkey.",
      "openfda": {
        "pma_number": [
          "P180047",
          "P010033"
        ],
        "registration_number": [
          "2182595",
          "1122376",
          "2029372",
          "9610240"
        ],
        "fei_number": [
          "2182595",
          "1000306617",
          "3003572099",
          "3002808212"
        ],
        "device_name": "Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}