{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "195370",
      "product_res_number": "Z-1648-2022",
      "event_date_initiated": "2022-07-18",
      "event_date_posted": "2022-08-29",
      "recall_status": "Open, Classified",
      "res_event_number": "90669",
      "product_code": "MOI",
      "k_numbers": [
        "K100344"
      ],
      "product_description": "Dimension Vista LOCI CA 15-3 Flex reagent cartridge.  In Vitro Diagnostic for the quantitative measurement of CA 15-3.  \nSiemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456",
      "code_info": "UDI:  \n0084276802852621340BB22120610464344840,  0084276802852622049BC23021810464344840,  \n0084276802852622112BF23042210464344840.   \n\nLot Numbers:  \nlot 21340BB  \tExp Date: 2022-12-06;  \nlot 22049BC (corrected lot number 9/8/2022)  \tExp Date: 2023-02-18;  \nlot 22112BF  \tExp Date: 2023-04-20.",
      "firm_fei_number": "2517506",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19702-2466",
      "additional_info_contact": "SAME\n800-441-9250",
      "reason_for_recall": "Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Siemens issued  US Customers Urgent Medical Device Correction (VC-22-02.A.US) and  OUS Customers Urgent Field Safety Notice (VC-22-02.A.OUS) dated July 2022 to inform them to use lot specific correlation factors with all in-date lots of Dimension Vista CA15-3. Letter states reason for recall, health risk and action to take:\nCalibrate/Recalibrate Dimension Vista LOCI CA 15-3 lots listed in Table 1 using any in date\nlot of Dimension Vista LOCI 7 Calibrator (SMN 10488446/ REF KC605).\n Enter lot specific correlation factors C0 and C1 in the Method Configuration screen per Flex reagent Lot listed below in Table 2. After applying correlation factors to the specified lot, product claims listed in the Instructions For Use (IFU) are met\nFor instructions on entering correlation factors please refer to the Dimension Vista System Operator s Guide Rev A 2017-03 or online iGuide (Advanced Functions Section); Method Configuration, Section 9, page 9-25.\n Process Quality Control (QC) after recalibration and entry of lot specific correlation factors.\n The correlation factors may create an upward QC shift. Please follow your current\nlaboratory process for adjusting QC ranges. Siemens is providing some examples of CA15-3 lot specific QC values calculated for the three in-date lots of Dimension Vista LOCI CA15-3. CA 15-3 lot specific bottle values for representative sets of QC materials are shown in Table 3.\n\nCorrelation Factors will remain in the LOCI CA 15-3 Method configuration until\nremoved manually or revised by the user.\n You may receive future shipments of lots listed in Table 1. Be sure to retain this\nletter in order to apply correlation factors to CA15-3 lots listed in Table 1.\n Subsequent lots may require correlation factors. An Alert Card will be included in\nthe subsequent lots with the lot specific correlation factors and lot specific QC.\n Please review this letter with your Medical Director.\n\nIf you have any questions, please contact your Siemens Healthineers Customer",
      "product_quantity": "129 units US; 159 units OUS",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿\nGermany, Italy, Switzerland.",
      "openfda": {
        "k_number": [
          "K981698",
          "K965141",
          "K964703",
          "K240403",
          "K042732",
          "K010588",
          "K181492",
          "K100344",
          "K982680",
          "K010796",
          "K980190",
          "K983690",
          "K971418",
          "K033036",
          "K192524",
          "K013984",
          "K233946",
          "K192777",
          "K022178",
          "K970695",
          "K001468",
          "K963926",
          "K072612",
          "K171605",
          "K963803",
          "K012357",
          "K964407",
          "K193489"
        ],
        "registration_number": [
          "3007111389",
          "3011989923",
          "9612316",
          "3000308930",
          "2521625",
          "2032839",
          "3002637618",
          "3002806944",
          "3005333358",
          "2250051",
          "3002642396",
          "2122870",
          "8020888",
          "2517506",
          "3002809144",
          "3005529799",
          "1319681",
          "1219913",
          "9610126",
          "1036362",
          "3012963943",
          "2020726",
          "8031673",
          "3006198300",
          "2432235"
        ],
        "fei_number": [
          "3007111389",
          "3011989923",
          "3002808328",
          "3000308930",
          "2521625",
          "3002637618",
          "3002806944",
          "3005333358",
          "2250051",
          "3002642396",
          "2122870",
          "2517506",
          "3002809144",
          "3005529799",
          "2967",
          "1219913",
          "1000136573",
          "1036362",
          "3007019572",
          "3012963943",
          "3002806559",
          "2020726",
          "3006198300",
          "3004185580",
          "2432235"
        ],
        "device_name": "System, Test, Immunological, Antigen, Tumor",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.6010",
        "device_class": "2"
      }
    }
  ]
}