{
  "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": "122026",
      "product_res_number": "Z-0032-2014",
      "event_date_initiated": "2013-08-20",
      "event_date_posted": "2013-10-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-11-13",
      "res_event_number": "66293",
      "product_code": "LOM",
      "pma_numbers": [
        "P050048S004"
      ],
      "product_description": "FSE Image Upgrade Kit, Catalog # 92019C\n\nThis kit is used to install and/or upgrade software used with the EVOLIS Microplate System.",
      "code_info": "Lot 122822",
      "firm_fei_number": "3008272466",
      "recalling_firm": "Bio-Rad Laboratories",
      "address_1": "6565 185th Ave NE",
      "city": "Redmond",
      "state": "WA",
      "postal_code": "98052-5039",
      "additional_info_contact": "Cindi Jinneman\n800-224-6723",
      "reason_for_recall": "The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA\nQuantitative Determination in EVOLIS APF version 6.0.",
      "root_cause_description": "Software change control",
      "action": "BioRad has sent an Urgent Product Correction letter dated August 19, 2013, to customers who had the EVOLIS FSE Upgrade Image Kit installed on the EVOLIS at their site by a Bio-Rad Laboratories Field Service Engineer (FSE).\n\nThis issue impacts laboratory only if you are running the MONOLISA Anti-HBs EIA Quantitative Determination method with EVOLIS APF version 6.0 and TimeLiner Data Management Software. If you use this Quantitative Determination method with EVOLIS APF version 6.0, please contact Bio-Rad Laboratories for additional information or assistance.\n\nBio-Rad Laboratories is currently developing and qualifying a software update CD consisting of the EVOLIS APF V6.0b and Timeliner Data Management Software to correct the issue.  The software update CD will be installed by Bio-Rad Field Service Engineers at each of the customer sites when\ninstalling the EVOLIS APF V6.0b.\n\nCustomers should contact Bio-Rad Laboratories at 1-800-224-6723, Option\n2 and then Option 3 for any questions about this product correction.",
      "product_quantity": "23 kits",
      "distribution_pattern": "US Distribution including the states of  FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA",
      "openfda": {
        "k_number": [
          "K260770"
        ],
        "pma_number": [
          "P080023",
          "P100032",
          "P060009",
          "P110029",
          "P790025",
          "P850044",
          "P030040",
          "P010050",
          "P180045",
          "P090028",
          "P210019",
          "P030049",
          "P840070",
          "P230015",
          "P050051",
          "P060003",
          "P210003",
          "P010051",
          "P870048",
          "P110041",
          "P180038",
          "P190017",
          "P100031",
          "P990038",
          "P830014",
          "P030026",
          "P100039",
          "P180048",
          "P010054",
          "P000044",
          "P060007",
          "P050049",
          "P010053",
          "P110022",
          "P190034",
          "P160019",
          "P190005",
          "P990042",
          "P060034",
          "P060035",
          "P780016",
          "P000014",
          "P110031",
          "P990044",
          "P060031",
          "P180039",
          "P990012",
          "P110025",
          "P060012",
          "P200017",
          "P090024",
          "P990043",
          "P030024",
          "P050048",
          "P990045",
          "P040004",
          "P990041",
          "P130015",
          "P180049",
          "P100001",
          "P010052",
          "P030029"
        ],
        "registration_number": [
          "2032682",
          "3012963943",
          "9612316",
          "3011989923",
          "1319681",
          "8023018",
          "9680746",
          "3002809144",
          "3005360469",
          "2029372",
          "9610126",
          "2250051",
          "8031673",
          "9610240",
          "9610746",
          "1219913",
          "3007111389",
          "3002642396",
          "3005333358",
          "3002806944",
          "2432235",
          "3008576040",
          "3008344661",
          "3000308930",
          "3032705"
        ],
        "fei_number": [
          "3002808328",
          "3012963943",
          "3005670738",
          "3003952975",
          "3002807272",
          "3011989923",
          "3002809144",
          "2250051",
          "2967",
          "3002806559",
          "1219913",
          "3002806557",
          "1000306617",
          "1000136573",
          "3007111389",
          "3002642396",
          "1000206808",
          "3005333358",
          "3002806944",
          "2432235",
          "3002808212",
          "3008576040",
          "3008344661",
          "3000308930",
          "3002701146"
        ],
        "device_name": "Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3172",
        "device_class": "2"
      }
    }
  ]
}