{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "194354",
      "product_res_number": "Z-1345-2022",
      "event_date_initiated": "2022-05-20",
      "event_date_created": "2022-07-07",
      "recall_status": "Open, Classified",
      "res_event_number": "90417",
      "product_code": "NQI",
      "k_numbers": [
        "K103502"
      ],
      "product_description": "CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood\nPart Number: 7900001",
      "code_info": "UDI-DI: (01)10888385000016(17)221004(10)S108\nLot Number:  S108\nExp. Date: 04Oct2022",
      "firm_fei_number": "3004153557",
      "recalling_firm": "Menarini Silicon Biosystems",
      "address_1": "3401 Masons Mill Rd Ste 100 3401 Masons Mill Rd",
      "address_2": "Ste 100",
      "city": "Huntingdon Valley",
      "state": "PA",
      "postal_code": "19006-3574",
      "additional_info_contact": "SAME\n215-830-0777",
      "reason_for_recall": "High number of total images/unassigned events including (dual positives) and the potential for false\npositive results being placed into the image gallery in some patient samples",
      "root_cause_description": "Process control",
      "action": "Menarini Silicon Biosystems issued notification telephone  Urgent Medical Device Correction Notification  CTC Kit Lot S108 to US on 5/20/22. Followed by  e-mail direct to consignees for US sites - May 23, 2022 and Coordination with Asia Pacific region and the EU with Local QA and RA from the regions. Letter states reason for recall, health risk and action to take:\nDiscontinue usage of Lot S108 and quarantine the lot in your inventory for\ndisposal.\n Review patient samples run with Kit Lot S108 which had results that were above\nthe cut-off. If you observe any images with the staining pattern of the false\npositive images shown below or there is any uncertainty regarding these images\nimpacting the patient's outcome from below the cutoff to above the cut-off, the\npatient sample should be repeated.\nReport any previous occurrence of unusually high number of total images/\nunassigned events or potential false positive events that have not already been\nreported to the Customer Technical Support.\n\" Complete and return the enclosed Confirmation of Receipt form no later than May\n31, 2022.\n\nIf you have additional questions about this issue, contact Customer Technical Support\nat +1-877-837-4339 option 2",
      "product_quantity": "484 units",
      "distribution_pattern": "CA\nFL\nIL\nIN\nMA\nMI\nNC\nNM\nNY\nOH\nON\nPA\nTX\n\nForeign: Italy, Shanghai, Singapore,",
      "openfda": {
        "k_number": [
          "K122821",
          "K060110",
          "K071729",
          "K073338",
          "K110406",
          "K062013",
          "K130794",
          "K052191",
          "K050145",
          "K050245",
          "K113181",
          "K103502",
          "DEN040001"
        ],
        "registration_number": [
          "1938173",
          "3003144120",
          "3004153557"
        ],
        "fei_number": [
          "1938173",
          "3004153557",
          "3004099094"
        ],
        "device_name": "System, Immunomagnetic, Circulating Cancer Cell, Enumeration",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.6020",
        "device_class": "2"
      }
    }
  ]
}