{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Grove City",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85753",
      "recalling_firm": "Tosoh Bioscience Inc",
      "address_1": "3600 Gantz Rd",
      "address_2": "N/A",
      "postal_code": "43123-1895",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic distribution nationwide. Foreign distribution to Chile, Costa Rica, Cayman Islands, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Republic of Panama, El Salvador, and Uruguay.",
      "recall_number": "Z-2423-2020",
      "product_description": "AIA-900 Analyzer, Part no. 022930, UDI 04560189283992",
      "product_quantity": "529",
      "reason_for_recall": "The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results.",
      "recall_initiation_date": "20200522",
      "center_classification_date": "20200623",
      "termination_date": "20240829",
      "report_date": "20200701",
      "code_info": "From customer letter: Serial numbers 10030810; 10101008; 10142204; 10212411; 10253902;   10263902 and higher serial numbers      Complete list:    (Distributed in US)  10030810  10050912  10071402  10101008  10142204  10162305  10202911  10212411  10222312  10253902  10263902  10273002  10303104  10303904  10313105  10313605  10333005  10333906  10343006  10343307  10353507  10353607  10353707R  10353807  10353907  10363507  10363608  10373108  10373408  10373508  10393108  10393208  10393308  10393908  10413009  10413509  10423409  10423909  10433009  10443110  10443210  10443310  10443710  10453310  10453410  10453810  10453910  10463010  10463110  10473111  10473211  10473311  10473411  10483411  10483511  10493111  10493411  10493711  10493911  10503011  10503111  10503211  10503311  10503612  10503912  10513412  10523912  10533012  10533112  10533212  10533412  10533612  10543012  10543212  10543412  10543512  10574301  10574601  10584702  10594502  10594602  10594702  10604902R  10614002  10614102  10614202  10614302  10624903  10634203  10634403  10634503  10644503  10644604  10644704  10644804  10644904  10654404  10654704  10654804  10654904  10664004  10664204  10674705  10674805  10684005  10684105  10684205R  10684405  10694406  10694606  10694706  10694806  10704006  10704807  10704907  10714007  10714107  10714207  10714307  10714407  10714507  10724808  10724908  10734008  10734108  10744509  10744709  10764310  10764410  10764510  10764610  10764710  10784111  10784411  10784511  10794011  10794111  10794211  10794311  10794411  10804312  10804412  10804612  10804712  10804812  10814012  10825701  10825801  10825901R  10835001  10835201  10855603  10855703  10855803  10865104  10865204  10865304  10865404  10885106  10885206  10885306  10885406  10895506  10895707  10895807  10895907  10905007  10905107  10905507  10905607  10905707  10905807  10905907  10915108  10915208  10925508  10935209  10975711  11036605  11036805  11036905  11046005  11046105  11046305  11046405  11046505  11046606  11046706  11066108  11066208  11066408  11066609  11066709  11066909  11076009  11076109  11076309  11076409  11076509  11076610  11086610  11086810  11086910  11096010  11096111  11096211  11106011  11127402  11127502  11127602  11127702  11147103  11167404  11167504  11167605  11167705  11167805  11167905  11177005  11177105  11177205  11177505  11177605  11177705  11177805  11177905  11187005  11187105  11187706  11187806  11197506  11197606  11197706  11197806  11197906  11207006  11207107  11217307  11217407  11217507  11217607  11217807  11217907  11227007  11227108  11227208  11227308  11227408  11237308  11237408  11237508  11247309  11247409  11247609  11247709  11257409  11257509  11257610  11257710  11257810  11257910  11267010  11267110  11267210  11267510  11277811  11287511  11287612  11287712  11297612  11297712  11297912  11318501  11318602  11318702  11318802  11318902  11328002  11328102  11328202  11328302  11338003  11338103  11338203  11338303  11338403  11338503  11348805  11348905  11358005  11358105  11358205  11358505  11358606  11358706  11358806  11368006  11368106  11368306  11368406  11378107  11378207  11378307  11378707  11378807  11378907  11388007  11398508  11398608  11408109  11408209  11408309  11418509  11418610  11418710  11418810  11418910  11428410  11428510  11428610  11428710  11448312  11448412  11448512  11448612  11469001  11469101  11469201  11469301  11489503    (Distributed Internationally)  10081002  10273603  10303804R  10343407R  10413909R  10423809R  10483211  10564601  10564701  10564901  10594002  10594802  10614402R  10634303R  10634603  10664304  10674505  10674605  10694506  10734208R  10734308  10744309  10744409  10744609  10855903  10865003  11006601  11026101  11026201  11026301  11026702  11026802  11026902  11046205R  11076209R  11086710  11106112  11106212  11106312  11106412  11106512  11187906  11197006  11197106  11197206  11197306  11247509  11247809  11267610  11297812  11368506  11368606  11368706  11368806  11368906  11378006  11398708  11398808  11398908  11408008  11438711  11438811  11438911  11448011  11448112  11448212  11479102  11479202  11479302"
    }
  ]
}