{
  "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": "196724",
      "product_res_number": "Z-0362-2023",
      "event_date_initiated": "2022-11-01",
      "event_date_posted": "2022-12-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-06-18",
      "res_event_number": "91097",
      "product_code": "CZP",
      "k_numbers": [
        "K955794"
      ],
      "product_description": "IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma\nCatalog Number: IA3832",
      "code_info": "GTIN: 05055273203882\nAll lots",
      "firm_fei_number": "1000361607",
      "recalling_firm": "Randox Laboratories Ltd.",
      "address_1": "55 Diamond Road",
      "city": "Crumlin",
      "state": "North",
      "country": "Ireland",
      "reason_for_recall": "Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to an elevation in Quality Control and Patient results of up to +13% for lgA and +51% for lgM respectively, which may lead to a delay in\nrunning patient samples or erroneous elevated test results",
      "root_cause_description": "Under Investigation by firm",
      "action": "Randox Laboratories extended recall notification to the  US Distribution center on 11/01/22 via email. The US distributor contacted customers on 11/1/22 via email . \nLetter states reason for recall, health risk and action to take:\nReview your instrument testing order in line with the Carryover Avoidance Technical\nBulletin (RXTB-0136}\n\" Update the RX user manual with the updated Carryover Avoidance Technical Bulletin\n(RXTB-0136} and ensure all operators are aware of the recommendations.\n\nDiscuss the contents of this notice with your Medical Director.\n\" Complete and return the response form 12187-QA to technical.services@randox.com\nwithin five working days.\nTransmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation.\n\nIf you have any questions or concerns, please contact Randox Technical\nServices",
      "product_quantity": "20 kits US in total",
      "distribution_pattern": "US Nationwide Distribution: CA, NC, NJ and WV,",
      "openfda": {
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          "K760146",
          "K812488",
          "K812253",
          "K843614",
          "K831102",
          "K962200",
          "K863352",
          "K955907",
          "K931806",
          "K871940",
          "K771603",
          "K800211",
          "K884040",
          "K823567",
          "K772251",
          "K890560",
          "K812633",
          "K873869",
          "K823566",
          "K800449",
          "K952309",
          "K832263",
          "K790479",
          "K772076",
          "K894418",
          "K842468",
          "K850582",
          "K861167",
          "K993927",
          "K880803",
          "K193525",
          "K812631",
          "K803274",
          "K822026",
          "K790703",
          "K855046",
          "K855009",
          "K983359",
          "K920014",
          "K955794",
          "K801283",
          "K900422",
          "K862763",
          "K770962",
          "K853467",
          "K024038",
          "K811125",
          "K862183",
          "K040435",
          "K791401",
          "K883492",
          "K060130",
          "K851284"
        ],
        "device_name": "Iga, Antigen, Antiserum, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5510",
        "device_class": "2",
        "registration_number": [
          "2050012",
          "3004493545",
          "3019906",
          "2050010",
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          "1181121",
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          "9610529",
          "9610806"
        ],
        "fei_number": [
          "2050012",
          "3004493545",
          "3019906",
          "2050010",
          "3002809144",
          "3002806560",
          "3005094123",
          "3016438761",
          "3003423869",
          "3002806778",
          "3000148879",
          "3002806559",
          "3003795116",
          "3013059683",
          "3009189893",
          "3001644026",
          "3003601075",
          "3005333358",
          "1000403749",
          "1181121",
          "3006198300"
        ]
      }
    }
  ]
}