{
  "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": "191732",
      "product_res_number": "Z-0678-2022",
      "event_date_initiated": "2022-01-25",
      "event_date_created": "2022-02-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-01-09",
      "res_event_number": "89493",
      "product_code": "LIQ",
      "k_numbers": [
        "K971585"
      ],
      "product_description": "meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box.\n\nThe ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.",
      "code_info": "Lot numbers 750030M481, Exp. 4/29/2022; 750030N482, Exp. 12/2/2022; and 750030N483, Exp. 5/17/2023.",
      "firm_fei_number": "1417592",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Ms. Karin Johnson\n866-359-1704",
      "reason_for_recall": "The product was incorrectly shipped at room temperature rather than refrigerated.",
      "root_cause_description": "Storage",
      "action": "The recalling firm, Medline Industries, LP, issued \"URGENT RECALL NOTIFICATION MEDLINE INDUSTRIES, INC. IMMEDIATE ACTION REQUIRED\" letters dated 1/25/2022 via first class mail on 1/25/2022.  The letters were flagged that immediate action was required and the product was identified  and the reason for recall was explained.  The required actions instructed the customer to:\n1) immediately check their stock for the affected item number and lot numbers listed in the attachment. Quarantine all affected product. \n2) The customer was to complete and return the response form after completion to indicate the amount of product they are destroying. Even if they do not have any affected product. \n3) If the product has been transferred to another individual or location in their organization, they are to notify them of the recall.\n\nOn 2/4/2022, an updated letter was issued via first class mail which removed lot 7869.391 as an affected lot number.  The lot number was also removed on the Destruction Form. \n\nIf you have any questions, please contact 866-359-1704.",
      "product_quantity": "19 kits",
      "distribution_pattern": "US Distribution was made to IL, FL, LA, MS, NC, OH, and TX.",
      "openfda": {
        "k_number": [
          "K861628",
          "K933587",
          "K862917",
          "K864811",
          "K912666",
          "K971585",
          "K884017",
          "K932384",
          "K861634",
          "K874375",
          "K883940",
          "K880821",
          "K990842",
          "K915137",
          "K860529",
          "K853554",
          "K853399",
          "K942286",
          "K964424",
          "K841243",
          "K854129",
          "K852969",
          "K972895",
          "K951208",
          "K965092",
          "K895805",
          "K841319",
          "K883935",
          "K861172",
          "K843367",
          "K850269",
          "K873740",
          "K834443"
        ],
        "registration_number": [
          "2182595",
          "2032839",
          "3022178699",
          "1524213",
          "3014150341",
          "2029372",
          "3005984081",
          "3005360469",
          "3003750284",
          "3003917514",
          "2030538",
          "3024463179",
          "2032682"
        ],
        "fei_number": [
          "3003952975",
          "3005670738",
          "2182595",
          "3022178699",
          "1524213",
          "3014150341",
          "3005984081",
          "3003750284",
          "3003917514",
          "3004185580",
          "3024463179",
          "1000520007",
          "1000306617"
        ],
        "device_name": "Enzyme Linked Immunoabsorbent Assay, Rotavirus",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3405",
        "device_class": "1"
      }
    }
  ]
}