{
  "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": "142164",
      "product_res_number": "Z-0556-2016",
      "event_date_initiated": "2015-11-23",
      "event_date_posted": "2015-12-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-02-24",
      "res_event_number": "72760",
      "product_code": "NJR",
      "product_description": "Granada Biphasic Broth\n\nThe product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.",
      "code_info": "REF 42722 - Lot Numbers 896, 897 & 899",
      "firm_fei_number": "1950204",
      "recalling_firm": "Biomerieux Inc",
      "address_1": "595 Anglum Rd",
      "city": "Hazelwood",
      "state": "MO",
      "postal_code": "63042-2320",
      "additional_info_contact": "Jeff Scanlan\n314-731-8694",
      "reason_for_recall": "FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.",
      "root_cause_description": "No Marketing Application",
      "action": "The firm, Biomerieux, sent an \"Urgent Product Removal Notice\" dated November 23, 2015 to its consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to confirm that the letter has been distributed and reviewed by all appropriate personnel, discontinue and discard any remaining inventory, store letter with your bioMerieux documentation and complete the attached Acknowledgement Form via fax to: (919) 620-3306 attention of: bioMerieux NA ComOps QA/RA.\n\nIf you have any questions or concerns, please contact your local bioMrieux Clinical Customer Service organization at (800) 682-2666.",
      "product_quantity": "24 cartons",
      "distribution_pattern": "US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.",
      "openfda": {
        "k_number": [
          "K173725",
          "K111860",
          "K112125",
          "K203429",
          "K181156",
          "K022504",
          "K060540",
          "K162772",
          "K090191",
          "K143312",
          "K222638",
          "K170557",
          "K182467",
          "K133503",
          "K121044",
          "K121539",
          "K062948",
          "K173250"
        ],
        "device_name": "Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3740",
        "device_class": "1",
        "registration_number": [
          "3007420875",
          "3006198300",
          "3012918440",
          "3026312356",
          "2024800",
          "2023365",
          "1119779",
          "3016838963",
          "3009613136",
          "1524213",
          "1528450",
          "3016733849",
          "3004530258"
        ],
        "fei_number": [
          "3007420875",
          "3006198300",
          "3012918440",
          "1000122536",
          "3026312356",
          "2024800",
          "2023365",
          "1119779",
          "3016838963",
          "3009613136",
          "1524213",
          "3016733849",
          "3004530258"
        ]
      }
    }
  ]
}