{
  "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": 3
    }
  },
  "results": [
    {
      "cfres_id": "188626",
      "product_res_number": "Z-2424-2021",
      "event_date_initiated": "2021-07-06",
      "event_date_created": "2021-09-03",
      "recall_status": "Open, Classified",
      "res_event_number": "88431",
      "product_code": "MOI",
      "k_numbers": [
        "K982680"
      ],
      "product_description": "Atellica IM BR 27.29 (BR) Assay 50 Test Kit-  in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.\nSMN: 10995478",
      "code_info": "All lots impacted. Kit lot numbers: 40476255 & 64505255 expiration date 2021-08-03, \nLot numbers: 89332257 & 05694257 expiration date 2021-11-10.",
      "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": "SAME\n508-668-5000",
      "reason_for_recall": "Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers",
      "root_cause_description": "Under Investigation by firm",
      "action": "Siemens Healthcare issued  Urgent Medical Device Correction (UMDC) via  FedEx beginning on 07/06/2021.  An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities beginning on 07/06/2021. \nLetter states reason for recall, health risk and action to take:\nPlease review this letter with your Medical Director.\nChange the BR assay Pack Calibration Interval on each Atellica IM analyzer from 10 days\nto 3 days. See Additional Information for instructions on changing the Pack Calibration\nInterval.\nAll Atellica IM BR assay kit lots can continue to be utilized with the updated Pack\nCalibration Interval of 3 days.\nContinue to follow the Atellica IM BR IFU claimed 28-day On-board Stability and 32-day Lot Calibration Intervals.\nComplete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.\nIf you have received any complaints of illness or adverse events associated with the\nproducts listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.\nPlease retain this letter with your laboratory records and forward this letter to those who may have received this product.\nIf you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.\nAdditional Information\nInstructions for Changing the Pack Calibration Interval on Atellica IM Analyzers\nInstructions for updating the BR Pack Calibration Interval from 10 days to 3 days on each Atellica\nIM analyzer are outlined below.\n1) Sign into Atellica IM analyzer as Labmanager user level\n2) In the Worklist Overview screen, move all BR results to Historical\n3) In the Setup screen, select Test Definition, select IM Test Definition, and select BR Test\n4) Select the Calibration Tab\n5) Under Pack C",
      "product_quantity": "580 units",
      "distribution_pattern": "Worldwide distribution.  US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam",
      "openfda": {
        "k_number": [
          "K072612",
          "K233946",
          "K010588",
          "K981698",
          "K963803",
          "K001468",
          "K982680",
          "K964407",
          "K042732",
          "K171605",
          "K240403",
          "K022178",
          "K192777",
          "K193489",
          "K012357",
          "K963926",
          "K010796",
          "K983690",
          "K181492",
          "K980190",
          "K970695",
          "K971418",
          "K965141",
          "K033036",
          "K013984",
          "K192524",
          "K100344",
          "K964703"
        ],
        "registration_number": [
          "3005529799",
          "3005333358",
          "9612316",
          "1319681",
          "2250051",
          "3012963943",
          "3007111389",
          "3002637618",
          "2521625",
          "3011989923",
          "3002642396",
          "2122870",
          "2517506",
          "1036362",
          "2020726",
          "8031673",
          "2432235",
          "3002809144",
          "3006198300",
          "3002806944",
          "2032839",
          "8020888",
          "1219913",
          "3000308930",
          "9610126"
        ],
        "fei_number": [
          "3005529799",
          "3005333358",
          "3007019572",
          "3002806559",
          "2250051",
          "3012963943",
          "3007111389",
          "3002637618",
          "3004185580",
          "1000136573",
          "2521625",
          "3011989923",
          "3002642396",
          "2122870",
          "2517506",
          "1036362",
          "2020726",
          "2432235",
          "3002809144",
          "3006198300",
          "3002806944",
          "3002808328",
          "1219913",
          "2967",
          "3000308930"
        ],
        "device_name": "System, Test, Immunological, Antigen, Tumor",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.6010",
        "device_class": "2"
      }
    }
  ]
}