{
  "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",
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  "results": [
    {
      "cfres_id": "135907",
      "product_res_number": "Z-1616-2015",
      "event_date_initiated": "2015-04-13",
      "event_date_posted": "2015-05-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-10-01",
      "res_event_number": "71045",
      "product_code": "GIF",
      "k_numbers": [
        "K081930",
        "K120771"
      ],
      "product_description": "COULTER DxH Diluent, Catalog No. 628017, Part No. A59956.\n\nFor use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.",
      "code_info": "Lot No. 3099980 - 3512190, expiration dates: 17 April 2015 - 26 August 2016.",
      "firm_fei_number": "2050012",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "city": "Brea",
      "state": "CA",
      "postal_code": "92821-6232",
      "reason_for_recall": "Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems.  The use of the DxH Diluent lots listed in the recall notice may eventually result in a compromised HGB chamber.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "An Urgent Medical Device Recall letter dated 4/13/15 was sent to customers who purchased the Coulter DxH Diluent.  The letter informs customers that Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems.  The letter informs customers of the problems identified and the actions to be taken.\nCustomers are instructed to complete and return the enclosed Response Form within 10 days.  Customers with questions are instructed to contact Customer Support Center via http://www.beckmancoulter.com/customersupport/support or call (800) 526-7694 in the US and Canada.  Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.",
      "product_quantity": "829,888 units total (659,584 units in US)",
      "distribution_pattern": "Worldwide Distribution -- Argentina; Brazil; Brunei Darussalam; Canada; Chile; Colombia; Hong Kong; India; Lebanon; Macao; Mexico; Panama; Philippines; Qatar; Singapore; Taiwan; Thailand; Trinidad and Tobago; United States, including Puerto Rico; and Uruguay.",
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        "device_name": "Diluent, Blood Cell",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.8200",
        "device_class": "1",
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