{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "195684",
      "product_res_number": "Z-1751-2022",
      "event_date_initiated": "2022-07-20",
      "event_date_created": "2022-09-16",
      "recall_status": "Open, Classified",
      "res_event_number": "90762",
      "product_code": "GKB",
      "product_description": "iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the reading chamber, and to the waste on the\niSED Automated ESR Analyzer \nPN: 112-13-002",
      "code_info": "Lot 4/22",
      "firm_fei_number": "3003855297",
      "recalling_firm": "Alcor Scientific, Inc.",
      "address_1": "20 Thurber Blvd",
      "city": "Smithfield",
      "state": "RI",
      "postal_code": "02917-1858",
      "additional_info_contact": "SAME\n401-737-3774",
      "reason_for_recall": "Primary Pump Tubing Spare Part is incorrect.  If the tubing is installed onto an ALCOR iSED ESR Analyzer, there is a potential of a biohazard leak from the iSEDs Probe Tube",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Alcor Scientific notified consignees via Emails  on 21 July 2022 that included an Advisory Notice (AN-001).  Letter states reason for recall, health risk and action to take:\n\"\tRemove from your inventory any Lot 4/22 Primary Pump Tubing Spare Part Kits (112-13-002).  Destroy this tubing.\n\"\tIf the tubing has been installed on any iSED ESR Analyzers, the tubing must be immediately replaced with new Primary Pump Tubing (112-13-002) from any other lot and Alcor must be notified of the locations where that tubing was installed.    \n\"\tComplete this form and return via email to techservice@alcorscientific.com within 3 days.  \n\nALCOR will replace all Primary Pump Tubing from Lot 4/22 that was shipped to your facility.",
      "product_quantity": "38 units",
      "distribution_pattern": "US Nationwide Distribution - FL, MA, MD, PA, SD, WI\nForeign:\nCroatia\nHonduras\nKorea",
      "openfda": {
        "device_name": "Device, Automated Sedimentation Rate",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5800",
        "device_class": "1",
        "registration_number": [
          "3004016977",
          "3003855297",
          "9614769",
          "3020704087",
          "1717966",
          "3043088937",
          "3006988008",
          "3043138885",
          "3038188172",
          "3017019647",
          "1950302",
          "9617475",
          "2249801",
          "3014325803",
          "9615056",
          "3004016971",
          "3024820199"
        ],
        "fei_number": [
          "3004016977",
          "3003855297",
          "3020704087",
          "3003238169",
          "1717966",
          "3043088937",
          "3006988008",
          "3043138885",
          "3038188172",
          "3017019647",
          "3002808075",
          "1950302",
          "1000186023",
          "3014325803",
          "3002807499",
          "3004016971",
          "3024820199"
        ],
        "k_number": [
          "K892522",
          "K890503"
        ]
      }
    }
  ]
}