{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "218861",
      "product_res_number": "Z-1658-2026",
      "event_date_initiated": "2026-02-06",
      "event_date_posted": "2026-03-27",
      "recall_status": "Open, Classified",
      "res_event_number": "98473",
      "product_code": "JTQ",
      "product_description": "BD Kiestra\" ReadA;\nCatalog No.: 446948.",
      "code_info": "Catalog No.: 446948;\nUDI-DI: 00382904469481;\nSerial Numbers: All;",
      "firm_fei_number": "3010141591",
      "recalling_firm": "BD KIESTRA LAB AUTOMATION",
      "address_1": "Marconilaan 6 6 marconilaan",
      "city": "Drachten",
      "country": "Netherlands",
      "reason_for_recall": "In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.",
      "root_cause_description": "Software Manufacturing/Software Deployment",
      "action": "On February 6, 2026 customers were contacted via phone call with a follow-up URGENT: Medical Device Correction letter were sent to customers on or about March 10, 2026.\nActions to be taken:\n1. Ensure the contents of this notification are read and understood.\n2. Share and post this customer letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness.\n3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements.\n4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via:\nWeb: MedWatch website at www.fda.gov/medwatch\nPhone: 1-800-FDA-1088 (1-800-332-1088)",
      "product_quantity": "82 units (7 US, 65 OUS)",
      "distribution_pattern": "Domestic: KS, MD, MN, NJ, TX, VA;\n\nInternational: Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Kuwait, Mexico, Morocco, Netherlands, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom;",
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        "device_name": "Bath, Incubators/Water, All",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2540",
        "device_class": "1"
      }
    }
  ]
}