{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "167108",
      "product_res_number": "Z-0115-2019",
      "event_date_initiated": "2018-07-24",
      "event_date_created": "2018-10-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-05-26",
      "res_event_number": "80954",
      "product_code": "JHS",
      "k_numbers": [
        "K962126"
      ],
      "product_description": "ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768\n\nProduct Usage:\n\nFor in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.",
      "code_info": "SMN 10309782  Lot # Expiry UDI # 35061 2019-02-10 (01)00630414056098(10)35061(17)20190210 39753 2020-06-11 (01)00630414056098(10)39753(17)20200611",
      "firm_fei_number": "1219913",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc",
      "address_1": "333 Coney St",
      "city": "East Walpole",
      "state": "MA",
      "postal_code": "02032-1516",
      "additional_info_contact": "508-668-5000",
      "reason_for_recall": "A potential bias was identified with certain kits compared to the internal standards.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On July 24, 2018 Siemens Healthineers issued Urgent Medical Device Recall notices to U.S. customers and Urgent Field Safety Notices to OUS customers.  \n\nThe following are Actions to be Taken by the Customer:\n\nCustomers using ADVIA Centaur CKMB Calibrator Lots ending in 64:\n- Review the notice with your Medical Director.\n- Review your inventory of these products and immediately order replacement ADVIA Centaur CKMB Calibrator kit lots ending in 68 by completing the Field Correction Effectiveness Check Form attached to the letter.\n- You may continue use of ADVIA Centaur CKMB Calibrator kit lots until\nreplacement product is received in your laboratory. \n- Upon receipt of replacement product in your laboratory, discontinue use of and discard the ADVIA Centaur CKMB Calibrator kit lots listed in Table 1 of the letter.\n- ADVIA Centaur CKMB Calibrator kit lots ending in 63 may continue to be used until the assigned expiration date.  \n- Refer to the Additional Information section for expected patient sample bias when transitioning to ADVIA Centaur CKMB Calibrator kit lots ending in 68.\n\nCustomers using ADVIA Centaur Master Curve Material:\n- Discontinue use of and discard the ADVIA Centaur MCM lots in Table 1.\n- Review your inventory of these products and order replacement ADVIA Centaur CKMB Master Curve Material by completing the Field Correction Effectiveness Check Form attached to the letter.\n- Utilize ADVIA Centaur CKMB MCM Lot 13384 and future lots.\n- Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days.\n\nCustomers using Atellica IM CKMB Calibrator Lots ending in 66:\n- Review your inventory of these products and immediately order replacement Atellica IM CKMB Calibrator kit lots ending in 69 by completing the Field Correction Effectiveness Check Form attached to the letter.\n- You may continue use of Atellica IM CKMB Calibrator kit lots in Table 1 until replacement product is received in your laboratory",
      "product_quantity": "379 sets",
      "distribution_pattern": "US Nationwide Distribution",
      "openfda": {
        "k_number": [
          "K781432",
          "K781690",
          "K962126",
          "K780504",
          "K790917",
          "K802521",
          "K801668",
          "K800028",
          "K792023",
          "K952250",
          "K941584",
          "K082226",
          "K945083",
          "K855188",
          "K903025",
          "K102706",
          "K990434",
          "K813406",
          "K790088",
          "K823211",
          "K062128",
          "K981495",
          "K803169",
          "K872029",
          "K790916",
          "K854708",
          "K160570",
          "K790343",
          "K790015",
          "K861387",
          "K900806",
          "K790918",
          "K820722",
          "K943024",
          "K883223",
          "K810997",
          "K843007",
          "K990439"
        ],
        "registration_number": [
          "2517506",
          "2432235",
          "9681753",
          "1219913",
          "3003795116",
          "1319809",
          "3006198300",
          "1319681",
          "9610126",
          "9610529",
          "2250051"
        ],
        "fei_number": [
          "1000305840",
          "3002806559",
          "2517506",
          "2432235",
          "3002806560",
          "1219913",
          "3003795116",
          "1000136573",
          "3006198300",
          "2250051",
          "3000303338"
        ],
        "device_name": "Differential Rate Kinetic Method, Cpk Or Isoenzymes",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1215",
        "device_class": "2"
      }
    }
  ]
}