{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "217436",
      "product_res_number": "Z-0959-2026",
      "event_date_initiated": "2025-10-30",
      "event_date_posted": "2025-12-18",
      "recall_status": "Open, Classified",
      "res_event_number": "98004",
      "product_code": "OYX",
      "k_numbers": [
        "K190076"
      ],
      "product_description": "Brand Name: Xpert BCR-ABL Ultra\nModel/Catalog Number: GXBCRABL-US-10",
      "code_info": "UDI: 07332940007102/\nLot Numbers: 1001456698, 1001463946, 1001472599, 1001477457, 1001480637, 1001483326, 1001500425",
      "firm_fei_number": "3004530258",
      "recalling_firm": "Cepheid",
      "address_1": "904 E Caribbean Dr",
      "city": "Sunnyvale",
      "state": "CA",
      "postal_code": "94089-1189",
      "additional_info_contact": "Darwa Peterson\n001-408-2427380",
      "reason_for_recall": "Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.",
      "root_cause_description": "Process design",
      "action": "On November 14, 2025, Cepheid issued a \"Urgent Medical Device Recall\" notification to affected consignees. Cepheid asked consignees to take the following actions: \n\n1. Cepheid recommends that laboratories and clinical facilities utilizing the Xpert BCR-ABL Ultra assay for quantification of BCR::ABL1 and ABL1 mRNA transcript levels in peripheral blood specimens from t(9;22)-positive chronic myeloid leukemia (CML) patients undergoing tyrosine kinase inhibitor (TKI) therapy, assess white blood cell count (WBCC) prior to testing in cases where elevated white blood cell count is suspected.\n\n2. If WBCCC exceeds 30,000 cells/uL, the specimen should be processed in  the accordance with the Retest Procedure for ERROR (Code 2008) or INVALID (Type 2) as detailed in the IFU for the following scenarios:\n\n- Cases where INVALID test results are observed and are associated with an elevated\nWBCC.\n- Cases of valid results in which an elevated WBCC has been observed.\n\n3. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality\nSystem documentation. \n\n4. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them with a copy of this letter.\n\n5. Please complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication.",
      "product_quantity": "6325 units",
      "distribution_pattern": "US: AL\tAR\tAZ\tCA\tCO\tFL\tGA\tIA\tIL\tKS\tKY\tLA\tMD\tME\tMI\tMN\tMO\tNC\tNE\tNH\tNJ\tNY\tOH\tPA\tRI\tTX\tVA\tWA\tWI\n\nOUS: Algeria\tArmenia\tAustralia\tAustria\tBahrain\tBangladesh\tBelgium\tBrazil\tBurkina Faso\tCambodia\tCanada\tCanary islands\tChile\tColombia\tCyprus\tCzech Republic\tDem. Rep. Congo\tDjibouti\tDominican Rep.\tEcuador\tEl Salvador\tEswatini\tFinland\tFrance\tFrenc.Polynesia\tGambia\tGeorgia\tGermany\tGhana\tGreece\tGuadeloupe\tGuatemala\tHonduras\tHong Kong\tIndia\tIndonesia\tIraq\tIsrael\tItaly\tJamaica\tJordan\tKazakhstan\tKenya\tKuwait\tLatvia\tLebanon\tLithuania\tLuxembourg\tMalawi\tMalaysia\tMauritania\tMauritius\tMexico\tMorocco\tMozambique\tMyanmar\tNetherlands\tNew Caledonia\tNew Zealand\tNicaragua\tNorway\tOman\tPap. New Guinea\tPeru\tPhilippines\tPoland\tPortugal\tQatar\tRep.of Congo\tReunion\tRwanda\tSaudi Arabia\tSenegal\tSeychelles\tSingapore\tSouth Africa\tSpain\tSri Lanka\tSweden\tSwitzerland\tTaiwan\tTajikistan\tTanzania\tThailand\tTogo\tTunisia\tUganda\tUnited Kingdom\tUruguay\tUtd.Arab Emir.\tVenezuela\tZambia\tZimbabwe",
      "openfda": {
        "k_number": [
          "K173492",
          "DEN160003",
          "K181661",
          "K221869",
          "K252243",
          "K190076"
        ],
        "registration_number": [
          "3007125666",
          "3004530258",
          "3016838963",
          "3003436513",
          "3021269066",
          "1550222",
          "2915274"
        ],
        "fei_number": [
          "3007125666",
          "3004530258",
          "3016838963",
          "3003436513",
          "3021269066",
          "1550222",
          "2915274"
        ],
        "device_name": "Bcr/Abl1 Monitoring Test",
        "medical_specialty_description": "Medical Genetics",
        "regulation_number": "866.6060",
        "device_class": "2"
      }
    }
  ]
}