{
  "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": "192039",
      "product_res_number": "Z-0710-2022",
      "event_date_initiated": "2022-02-11",
      "event_date_created": "2022-03-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-04-14",
      "res_event_number": "89603",
      "product_code": "OOI",
      "product_description": "Alinity m Integrated Reaction Units (IRU)",
      "code_info": "List Number 09N26-010, Lot Numbers/UDI:\n1) 766233 / (01)20884999047864(10)766233(11)210614(240)09N26-010\n2) 770433 / (01)20884999047864(10)770433(11)210621(240)09N26-010\n3) 771200 / (01)20884999047864(10)771200(11)210712(240)09N26-010\n4) 771201 / (01)20884999047864(10)771201(11)210719(240)09N26-010\n5) 773642 / (01)20884999047864(10)773642(11)210723(240)09N26-010",
      "firm_fei_number": "3005248192",
      "recalling_firm": "Abbott Molecular, Inc.",
      "address_1": "1300 E Touhy Ave",
      "city": "Des Plaines",
      "state": "IL",
      "postal_code": "60018-3315",
      "additional_info_contact": "Ray Bastian\n224-361-7000",
      "reason_for_recall": "There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On February 11, 2022, Abbott Molecular issued a Product Recall letter to all\ncustomers who received Integrated Reaction Unit (IRU) List Number 09N26-010 Lot\nNumbers 766233, 770433, 771200, 771201, and 773642 used with the Alinity m System.\nConsignees must complete and return the included customer reply form.\n\nCustomers are instructed to follow the Necessary Actions outlined in the Customer Letter:\nDiscontinue use of and discard all remaining inventory of IRU Lots 766233, 770433,\n771200, 771201, and 773642. To coordinate replacement, contact your local Molecular\nDiagnostics at Abbott representative.\nIf RVs are found inside the instrument with no cap and there are associated 1998 errors,\nplease contact an Abbott representative to inspect the instrument. Results generated between the onset of the associated 1998 errors and the identification of the RV with no cap inside the instrument should be considered presumptive. Retesting of samples that yielded positive results during this timeframe should be considered.",
      "product_quantity": "3063 kits",
      "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MI, MO, NC, NJ, NY, OK, RI, SD, TX, WA, and WI.",
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        "device_name": "Real Time Nucleic Acid Amplification System",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2570",
        "device_class": "2"
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    }
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}