{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "169495",
      "product_res_number": "Z-0687-2019",
      "event_date_initiated": "2018-11-01",
      "event_date_created": "2019-01-03",
      "recall_status": "Open, Classified",
      "res_event_number": "81682",
      "product_code": "LOM",
      "pma_numbers": [
        "P100001"
      ],
      "product_description": "VITROS Anti-HBe Reagent Pack, Cat No. 6801816\n\nProduct Usage:\nFor the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Further assessment of HBV infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. VITROS Anti-HBe test performance has not been established for the monitoring of HBV disease or therapy. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.",
      "code_info": "All expired, in-date, and future lots released.",
      "firm_fei_number": "3007111389",
      "recalling_firm": "ORTHO-CLINICAL DIAGNOSTICS",
      "address_1": "Felindre Meadows",
      "city": "Bridgend",
      "country": "United Kingdom",
      "reason_for_recall": "The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.",
      "root_cause_description": "Device Design",
      "action": "On November 1, 2018, a customer letter was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail to all customers who could process the affected\nproducts to inform them of the potential interference of\nbiotin at levels lower than stated in the IFUs and that Ortho is in the process of revising the IFUs for the\naffected products. Ortho recommended customers follow normal laboratory procedures for troubleshooting of\nsamples containing other assay interferences and it was acceptable to continue using the affected products.\nIf you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.",
      "product_quantity": "3429 units (100 tests per unit)",
      "distribution_pattern": "Worldwide Distribution - US Nationwide domestic distribution. International distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, India, France, Japan, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.",
      "openfda": {
        "k_number": [
          "K260770"
        ],
        "pma_number": [
          "P990041",
          "P230015",
          "P180038",
          "P100032",
          "P060012",
          "P030040",
          "P060035",
          "P110025",
          "P060007",
          "P050048",
          "P050049",
          "P030026",
          "P210003",
          "P160019",
          "P080023",
          "P030024",
          "P990042",
          "P010051",
          "P010053",
          "P990038",
          "P990044",
          "P130015",
          "P030049",
          "P110029",
          "P870048",
          "P200017",
          "P840070",
          "P990043",
          "P190017",
          "P190034",
          "P000044",
          "P110041",
          "P990045",
          "P180049",
          "P110031",
          "P000014",
          "P990012",
          "P110022",
          "P100039",
          "P010052",
          "P060003",
          "P180039",
          "P090024",
          "P060031",
          "P040004",
          "P010050",
          "P190005",
          "P100031",
          "P830014",
          "P180048",
          "P790025",
          "P090028",
          "P210019",
          "P030029",
          "P850044",
          "P180045",
          "P060034",
          "P050051",
          "P780016",
          "P010054",
          "P060009",
          "P100001"
        ],
        "registration_number": [
          "2432235",
          "9612316",
          "8031673",
          "8023018",
          "3005360469",
          "3002642396",
          "3008576040",
          "3002809144",
          "3007111389",
          "1219913",
          "3011989923",
          "2029372",
          "9610126",
          "2250051",
          "3002806944",
          "9680746",
          "3008344661",
          "9610240",
          "2032682",
          "9610746",
          "3000308930",
          "1319681",
          "3005333358",
          "3012963943",
          "3032705"
        ],
        "fei_number": [
          "3002808328",
          "2432235",
          "3005670738",
          "3002806559",
          "1000206808",
          "3002807272",
          "3002642396",
          "3008576040",
          "3002809144",
          "3007111389",
          "1000306617",
          "1219913",
          "3011989923",
          "3002701146",
          "2250051",
          "3002806944",
          "3003952975",
          "3008344661",
          "1000136573",
          "3002808212",
          "3000308930",
          "2967",
          "3005333358",
          "3012963943",
          "3002806557"
        ],
        "device_name": "Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3172",
        "device_class": "2"
      }
    }
  ]
}