{
  "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,
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  },
  "results": [
    {
      "cfres_id": "220338",
      "product_res_number": "Z-2460-2026",
      "event_date_initiated": "2026-04-30",
      "event_date_posted": "2026-06-16",
      "recall_status": "Open, Classified",
      "res_event_number": "98979",
      "product_code": "GGN",
      "k_numbers": [
        "K202101"
      ],
      "product_description": "directCHECK ACT-LR whole blood quality control, level 2\nModel/Catalog Number: DCGLR-2",
      "code_info": "Lot #: A6DLA001\n\nUnique Device Identifier: 10711234170373",
      "firm_fei_number": "2250033",
      "recalling_firm": "Accriva Diagnostics, Inc.",
      "address_1": "6260 Sequence Dr",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4358",
      "additional_info_contact": "Paula Morgan\n001-858-2632590",
      "reason_for_recall": "Assayed Whole blood control contains labeling with incorrect performance range.",
      "root_cause_description": "Process control",
      "action": "On May 8, 2026 Accriva Diagnostics, issued a Urgent Medical Device Recall Notification to affected consignees via E-Mail.. Accriva asked consignees to take the following actions: \n\n1. Please forward this communication to those within your organization who need to become aware\n2. Forward the enclosed customer notification to all other organizations where affected devices may have been transferred to.\n3. Forward the enclosed customer notification to those in your organization that are responsible for performing quality control testing and/or supervise testing.\n4. Please check your inventory to determine if you have any boxes of directCHECK Whole BloodControls. If you have this product in stock, do NOT use.\n5. Please destroy all impacted boxes and document on the enclosed form.\n6. Please read the instructions on the Tracking Form and complete and return the form to Accriva Diagnostics, Inc.\n7. If you have any technical questions, please contact Technical Services at 1-800-678-0710 Option 3 or e-mail techsupport.na@werfen.com.",
      "product_quantity": "6060",
      "distribution_pattern": "Worldwide - US Nationwide  distribution including in the states of AL, AR, AZ, CA, FL, GA, \tID, IL, IN, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, WA, \tWI, WV and the countries of Canada, Hong Kong, Spain.",
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        "device_name": "Plasma, Coagulation Control",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5425",
        "device_class": "2"
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