{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "219697",
      "product_res_number": "Z-2171-2026",
      "event_date_initiated": "2026-04-01",
      "event_date_posted": "2026-05-12",
      "recall_status": "Open, Classified",
      "res_event_number": "98754",
      "product_code": "LCO",
      "k_numbers": [
        "K071255"
      ],
      "product_description": "ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A",
      "code_info": "UDI-DI: 03663537018763;\nLot Number: FD1265",
      "firm_fei_number": "3005017664",
      "recalling_firm": "Aniara Diagnostica LLC",
      "address_1": "7768 Service Center Dr",
      "city": "West Chester",
      "state": "OH",
      "postal_code": "45069-2442",
      "additional_info_contact": "513-770-1993",
      "reason_for_recall": "Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.",
      "root_cause_description": "Labeling Change Control",
      "action": "A Field Corrective Action notification letter dated 3/30/26 was sent to customers.\n\nActions implemented by HYPHEN BioMed:\n-Confirmation of the existence of a flyer discrepancy affecting 95 kits from lot FD1265.\n- Request for quarantine of the affected kits in US agent warehouse.\n-Coordination with US agent for notification of the impacted end users.\n-investigation to define the root cause and to establish corrective and preventive actions.\n\nActions to be implemented by the end user:\n1. Check the TAV flyer included in their kit.\n- If the flyer matches the correct version (dated 18 October 2024) - No action is required.\n- If the flyer corresponds to the incorrect version (dated I October 2024) - proceed to step 2\n2. Destroy the incorrect TAV flyer.\nThe outdated flyer included in the kit must be immediately removed and destroyed, as well as any paper or electronic copy that could have been done in end-user facility, to prevent further use.\n3. Replace the incorrect flyer with the corrected version.\nUse the corrected TAV flyer provided with this notice for all future testing\n4. Return the completed and signed form to your local distributor before April 15th, 2026.\n\nFor any question or information regarding this notification, please contact vigilance team, by email at VigilanceHBM@hyphen-biomed.com.",
      "product_quantity": "359 units",
      "distribution_pattern": "US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI",
      "openfda": {
        "k_number": [
          "K040293",
          "K243374",
          "K983379",
          "K153137",
          "K862774",
          "K890633",
          "K071255",
          "K003767",
          "K201570",
          "K201311",
          "K071781",
          "K053559",
          "K170854"
        ],
        "device_name": "Platelet Factor 4 Radioimmunoassay",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7695",
        "device_class": "2",
        "registration_number": [
          "9710666",
          "3037000637",
          "2183608",
          "1217183",
          "3004434070",
          "9610746",
          "2245451"
        ],
        "fei_number": [
          "3003565434",
          "3002806557",
          "3037000637",
          "2183608",
          "1217183",
          "3004434070",
          "2245451"
        ]
      }
    }
  ]
}