{
  "format": "devicerts.device.v1",
  "cite_as": "IRISpec CA/CB/CC URINE CHEMSITRY CONTROLS, Beckman Coulter Ireland Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/irispec-800-7702 (data as of 2026-11-14).",
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    "markdown_url": "https://devicerts.com/devices/irispec-800-7702.md",
    "publisher": "deviCERTS (devicerts.com)",
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      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
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        "url": "https://ec.europa.eu/tools/eudamed"
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    "registry_records_last_synced": "2026-10-23",
    "status_as_of": "2026-11-14",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/irispec-800-7702",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "IRISpec CA/CB/CC URINE CHEMSITRY CONTROLS",
    "registry_name": "IRISpec CA/CB/CC URINE CHEMSITRY CONTROLS",
    "url": "https://devicerts.com/devices/irispec-800-7702",
    "manufacturer": {
      "name": "Beckman Coulter Ireland Inc.",
      "url": "https://devicerts.com/manufacturers/beckman-coulter-ireland-inc",
      "country": "Ireland",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
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    },
    "classification": [
      {
        "class": "IVD General",
        "system": "EU IVDD"
      },
      {
        "class": "Class I",
        "system": "US FDA"
      }
    ],
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      {
        "label": "Catalogue number",
        "values": [
          {
            "value": "800-7702",
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            ]
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        "label": "Primary DI / UDI-DI",
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          {
            "value": "10837461002680",
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      {
        "label": "Basic UDI-DI",
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            "value": "B-10837461002680",
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        ]
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      {
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          {
            "value": "K072640",
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              "FDA GUDID (AccessGUDID)"
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          }
        ]
      }
    ],
    "product_codes": [
      "JJW"
    ],
    "emdn": [
      {
        "code": "W01010999",
        "term": "MULTIPLE PARAMETERS URINE TESTING - OTHER"
      }
    ],
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      {
        "code": "30219",
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      }
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  },
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      "region": "European Union",
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      "number": "B-10837461002680",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "10837461002680",
      "date": "2026-09-11",
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      "number_label": "UDI-DI",
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      "date": "2016-09-07",
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      "expires": null,
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    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K072640",
      "number_label": null,
      "device_udi_di": null,
      "date": "2007-12-21",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-0093-2025",
      "classification": "Class III",
      "status": "ongoing",
      "initiated": "2024-07-16",
      "reason": "Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.",
      "applies": "this device",
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    },
    {
      "number": "Z-0777-2023",
      "classification": "Class II",
      "status": "ongoing",
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      "reason": "Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212",
      "applies": "this device",
      "via": "K072640"
    }
  ],
  "eu_market_availability": null,
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          "label": "Trade name",
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            {
              "value": "IRISpec CA/CB/CC Urine Chemistry Controls",
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              "value": "IRISpec",
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          ]
        },
        {
          "label": "Generic name",
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            {
              "value": "Multiple urine analyte IVD, control",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Model / Ref / Catalog",
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          "label": "EU registration type",
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          "label": "EU market of registration",
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              "value": "Ireland",
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        },
        {
          "label": "GUDID distribution status",
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            {
              "value": "In Commercial Distribution",
              "registries": [
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          ]
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              "registries": [
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        {
          "label": "Professional testing",
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}