{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
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  "results": [
    {
      "status": "Ongoing",
      "city": "Huntingdon Valley",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90417",
      "recalling_firm": "Menarini Silicon Biosystems",
      "address_1": "3401 Masons Mill Rd Ste 100",
      "address_2": "N/A",
      "postal_code": "19006-3574",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "CA FL IL IN MA MI NC NM NY OH ON PA TX  Foreign: Italy, Shanghai, Singapore,",
      "recall_number": "Z-1345-2022",
      "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  Part Number: 7900001",
      "product_quantity": "484 units",
      "reason_for_recall": "High number of total images/unassigned events including (dual positives) and the potential for false  positive results being placed into the image gallery in some patient samples",
      "recall_initiation_date": "20220520",
      "center_classification_date": "20220707",
      "report_date": "20220713",
      "code_info": "UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number:  S108 Exp. Date: 04Oct2022",
      "more_code_info": ""
    }
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}