{
  "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": "198148",
      "product_res_number": "Z-1143-2023",
      "event_date_initiated": "2022-12-22",
      "event_date_posted": "2023-02-17",
      "recall_status": "Open, Classified",
      "res_event_number": "91552",
      "product_code": "LOM",
      "product_description": "ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pediatric (2-21 years old) and adult serum, EDTA plasma, or lithium heparin.\nSiemens Material Number (SMN): 10720831",
      "code_info": "UDI:\n(01)00630414167923(10)B34847(17)20230309\n(01)00630414167923(10)B34848(17)20230309\n(01)00630414167923(10)B35113(17)20230629.\n\nLot Numbers:\nB34847, B34848, B35113.\n\nAffects all current and future lots of the ADVIA Centaur XP and ADVIA Centaur XPT HBeAg assay until a solution is Implemented.",
      "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": "Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive when HBeAg testing follows aHBe2 testing, regardless of whether both tests are performed on the same sample",
      "root_cause_description": "Under Investigation by firm",
      "action": "Siemens Health issued an Urgent Medical Device Correction (UMDC CC 23-02.A.US) to US customers on 12/22/2022 . The UMDC provides instructions to customers to run the aHBe2 and HBeAg assays on separate systems if possible or to run all aHBe2 tests together and perform the Daily Cleaning Procedure before the HBeAg assay to mitigate the interference. Letter states reason for recall, health risk and action to take:\n\nPlease review this letter with your Medical Director.\nIf you have multiple ADVIA Centaur XP or ADVIA Centaur XPT systems in your laboratory,\nSiemens recommends testing the ADVIA Centaur aHBe2 and ADVIA Centaur HBeAg\nassays on separate systems to avoid potential interference.\nIf you are testing the ADVIA Centaur HBeAg and ADVIA Centaur aHBe2 assays on the\nsame ADVIA Centaur XP or ADVIA Centaur XPT system, test all aHBe2 samples together\nfollowed by the Daily Cleaning Procedure (DCP) prior to testing the HBeAg assay to\nmitigate the interference. Perform HBeAg Quality Control testing prior to HBeAg patient\nsample testing.\n\nQuestions, contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.",
      "product_quantity": "158 units",
      "distribution_pattern": "US Nationwide distribution in the states of GA, UT.",
      "openfda": {
        "k_number": [
          "K260770"
        ],
        "pma_number": [
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          "P000044",
          "P080023",
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          "P110025",
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          "P780016",
          "P100001",
          "P060009",
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          "P990012",
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          "P100032",
          "P840070",
          "P060003",
          "P180048",
          "P110029",
          "P100031",
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          "P210019"
        ],
        "registration_number": [
          "3007111389",
          "3011989923",
          "9612316",
          "3000308930",
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          "2032682",
          "8031673",
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        ],
        "fei_number": [
          "3007111389",
          "3011989923",
          "3002808328",
          "3000308930",
          "3002807272",
          "3002701146",
          "3002808212",
          "3002806944",
          "3005333358",
          "2250051",
          "3002642396",
          "3005670738",
          "3002809144",
          "3008576040",
          "2967",
          "1219913",
          "3003952975",
          "3008344661",
          "1000136573",
          "1000306617",
          "1000206808",
          "3012963943",
          "3002806559",
          "2432235",
          "3002806557"
        ],
        "device_name": "Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3172",
        "device_class": "2"
      }
    }
  ]
}