{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "222883",
      "product_res_number": "Z-0301-2027",
      "event_date_initiated": "2026-09-11",
      "event_date_posted": "2026-10-27",
      "recall_status": "Open, Classified",
      "res_event_number": "99931",
      "product_code": "JJH",
      "product_description": "EMAG system\r\nModel/Catalog Number: 418591/418591U\r\nProduct Description: Nucleic acid sample preparation instrument IVD, automated",
      "code_info": "UDI-DI 357302BUDI000544TP\n\nSerial Numbers\nIM03343\nIM03283\nIM03104\nIM03329\nIM03376\nIM03474\nIM03321\nIM03071\nIM03175\nIM03194\nIM03515\nIM03516\nIM03240\nIM03478\nIM03479\nIM03482\nIM03034\nIM03092\nIM03378\nIM03414\nIM03177\nIM03193\nIM03506\nIM3054\nIM03439\nIM03350\nIM03380\nIM03131\nIM03148\nIM03153\nIM03275\nIM03314\nIM03351",
      "firm_fei_number": "1000611339",
      "recalling_firm": "BioMerieux SA",
      "address_1": "Chemin De L'Orme",
      "city": "Marcy L'Etoile",
      "country": "France",
      "additional_info_contact": "bioMerieux Customer Service Center\n800-6822666",
      "reason_for_recall": "Delayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error, Error 10003 Heater timeout after updating to recent firmware SP4 Patch 2",
      "root_cause_description": "Software change control",
      "action": "The firm began notifying consignees on September 11, 2026. Customers were informed they may continue use of EMAG systems and there is no risk of false results. In case of 10003 error heater time-out during an extraction protocol, customers are instructed to reset the system to run the protocol again to prevent delay/loss of sample.\n\nThe company will contact customers to schedule a bioMerieux Field Service Engineer (FSE) visit to update affected EMAG systems to the previous firmware patch SP4 Patch 1 to fix the issue.",
      "product_quantity": "33",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of CA, IN, KS, LA, MN, MO, NY, OH, and TX. The countries of Canada, United Kingdom, Sweden, France, Norway, Netherlands, Belgium, Denmark, Germany, Austria.",
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        "device_name": "Clinical Sample Concentrator",
        "medical_specialty_description": "Clinical Chemistry",
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}