{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "160396",
      "product_res_number": "Z-0491-2018",
      "event_date_initiated": "2017-06-11",
      "event_date_created": "2018-01-31",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-12-31",
      "res_event_number": "78776",
      "product_code": "KHO",
      "product_description": "TosohAutomated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930.\nProduct Usage:\nThe AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.",
      "code_info": "All Photo Interrupter sensors that are current in AIA-900 analyzers with serial number(S/N) 10000103 to S/N 11147003.",
      "firm_fei_number": "3005529799",
      "recalling_firm": "Tosoh Bioscience Inc",
      "address_1": "3600 Gantz Rd",
      "city": "Grove City",
      "state": "OH",
      "postal_code": "43123-1895",
      "additional_info_contact": "614-317-1909",
      "reason_for_recall": "This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Customers were sent a recall notification by email on July 11, 2017 informing them that their local Field Service Engineer would contact them to make arrangements to proactively replace the affected parts. Follow up notifications will be by Federal Express with verification of delivery.",
      "product_quantity": "565 total devices U.S.",
      "distribution_pattern": "Worldwide Distribution - U.S. Nationwide - Latin America",
      "openfda": {
        "k_number": [
          "K811019",
          "K913130",
          "K780362",
          "K973547",
          "K923021",
          "K822942",
          "K952719",
          "K791329",
          "K760506",
          "K830624",
          "K872803",
          "K780122",
          "K790235",
          "K950415",
          "K760261",
          "K813146",
          "K822772",
          "K894159",
          "K930689",
          "K920888",
          "K823112",
          "K851984",
          "K822701",
          "K790236",
          "K860309",
          "K112161",
          "K813540",
          "K871550",
          "K901674",
          "K926131",
          "K895240",
          "K935047",
          "K802579",
          "K780242",
          "K962919",
          "K971103",
          "K890908",
          "K780031"
        ],
        "registration_number": [
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          "3005529799",
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        ],
        "fei_number": [
          "3033507883",
          "3005529799",
          "3010381606",
          "2024800",
          "3012516456",
          "2967",
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          "3006198300",
          "3007606081",
          "3034246205",
          "3009092698",
          "3007349751",
          "3005345870",
          "3017356406",
          "3007113174",
          "3002710220",
          "3005273623",
          "3004529019",
          "3002642396",
          "3042250641",
          "3005174594",
          "3000308930",
          "3003366417",
          "3004205692",
          "3014397113",
          "2022994",
          "2517506",
          "3013982035",
          "3002637618",
          "3003542872",
          "3038371335",
          "3003559191",
          "3016245321",
          "3010324880",
          "3012963943",
          "3009491259",
          "3013960814",
          "3029916095",
          "3010082909",
          "3029906631",
          "3021090658",
          "3013223546",
          "3002808498",
          "3014150341",
          "3002792284",
          "1000136573",
          "3000215862",
          "2024674"
        ],
        "device_name": "Fluorometer, For Clinical Use",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2560",
        "device_class": "1"
      }
    }
  ]
}