{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "189710",
      "product_res_number": "Z-0243-2022",
      "event_date_initiated": "2021-09-30",
      "event_date_created": "2021-11-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-01-18",
      "res_event_number": "88844",
      "product_code": "JSC",
      "product_description": "API 50 CH, Model 50300",
      "code_info": "Model 50300, Lot 1008679230  UDI: (01)03573026087401 (17)220330 (10)1008679230",
      "firm_fei_number": "3002769706",
      "recalling_firm": "bioMerieux, Inc.",
      "address_1": "100 Rodolphe St",
      "city": "Durham",
      "state": "NC",
      "postal_code": "27712-9402",
      "additional_info_contact": "bioMerieux Customer Service Center\n919-620-2000",
      "reason_for_recall": "There is potential to provide an incorrect organism identification.",
      "root_cause_description": "Material/Component Contamination",
      "action": "Notification letters were issued to customers via FedEx Priority Overnight mail during the week of October 4, 2021.\n\nCustomers are asked to do the following:\n-Discontinue use of and discard any remaining inventory of lot 1008679230.\n-For tests previously performed using API 50 CH Ref. 50300 lot# 1008679230, we\nare asking you to identify any possible incorrect identification test result due to a\nfalse positive reaction of test 34, analyze the related risks and to determine\nappropriate actions, if relevant.\n-Complete the Acknowledgement Form in Attachment A and return it to your local\nbioMrieux representative to confirm receipt of this notice.\n-Distribute this information to all appropriate personnel in the laboratory, retain a\ncopy in your files.\n-Contact your local bioMrieux representative for product compensation.\n\nConsignees will perform destruction activities at their site.",
      "product_quantity": "1382 kits",
      "distribution_pattern": "Distribution in WI, NY, and SD",
      "openfda": {
        "k_number": [
          "K790615",
          "K821600",
          "K832620",
          "K820795",
          "K803026",
          "K800427",
          "K811132",
          "K832619",
          "K813615",
          "K790619",
          "K791292",
          "K820796",
          "K841221",
          "K821610",
          "K781372",
          "K811602",
          "K821598",
          "K790687",
          "K791623",
          "K790613",
          "K850143",
          "K842849",
          "K791478",
          "K822487",
          "K790625",
          "K800428",
          "K813611",
          "K791291",
          "K811056",
          "K802408",
          "K833300",
          "K791193",
          "K832569",
          "K811323",
          "K792056",
          "K830437",
          "K812335",
          "K790614",
          "K842852",
          "K800429",
          "K821597",
          "K790620",
          "K791194",
          "K790616",
          "K821601",
          "K822665",
          "K821864",
          "K800426",
          "K841219",
          "K791171",
          "K832570",
          "K820840"
        ],
        "device_name": "Culture Media, General Nutrient Broth",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2350",
        "device_class": "1",
        "registration_number": [
          "3005182157",
          "2916932",
          "1111096",
          "1924669",
          "9615754",
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          "8010096",
          "1210083",
          "2022807",
          "3009547954",
          "2016672",
          "9680687"
        ],
        "fei_number": [
          "3005182157",
          "1000220444",
          "1111096",
          "2916932",
          "1924669",
          "3015715780",
          "3005182159",
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          "3027341451",
          "3003285777",
          "1210083",
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          "3009547954",
          "3008237827"
        ]
      }
    }
  ]
}