{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "215639",
      "product_res_number": "Z-0408-2026",
      "event_date_initiated": "2025-08-08",
      "event_date_posted": "2025-10-28",
      "recall_status": "Open, Classified",
      "res_event_number": "97457",
      "product_code": "GIM",
      "k_numbers": [
        "K971221"
      ],
      "product_description": "Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322",
      "code_info": "UDI-DI: 29120017574488(Rack), 39120017574485(Case). Lot: B250139Q, Expiration: 01/09/2026",
      "firm_fei_number": "3001451379",
      "recalling_firm": "Greiner Bio-One North America, Inc.",
      "address_1": "4238 Capital Dr",
      "city": "Monroe",
      "state": "NC",
      "postal_code": "28110-7681",
      "additional_info_contact": "Greiner Bio-One Technical Service\n800-515-8112",
      "reason_for_recall": "Blood collection tubes  were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Greiner issued an Urgent Product Recall notice to its consignees on 08/19/2025 via email and fax.  The notice explained the issue and requested the following:  \n\"Immediate Actions Required\n1. Stop Distribution & Isolate Inventory\nImmediately cease distribution of the affected lot and segregate all remaining units.\n2. Select ONE of the following notification options:\nA. Customer Notification by Greiner Bio-One\no Complete the attached Product Disposition Site Confirmation form.\no Email the form to recalls.us@gbo.com or fax to 877-217-7927.\no Provide an Excel list of all customers including, if applicable, subdistributors who received the affected product, containing:\n. Facility name and address (city, state, ZIP)\n. Contact name, email, and phone number for Clinical/Laboratory Director or Supply\nChain\n. Date(s) and quantity shipped\no Greiner will handle direct customer notification and coordinate product return/credit.\nB. Customer Notification by Distributor\no Use the customer letter provided by Greiner Bio-One.\no Contact all customers who received the affected lot, including any sub-distributors.\no Conduct follow-up with non-responders and document effectiveness checks per FDA\nguidance: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industryguidance-recalls\"  \nFor questions regarding this recall, please contact:  Greiner Bio-One Technical Service,  Phone: 800-515-8112, Fax: 877-217-7927, Email: recalls.us@gbo.com",
      "product_quantity": "504,000",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
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          "3002902735",
          "1000112968",
          "3003737899",
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        ],
        "device_name": "Tubes, Vacuum Sample, With Anticoagulant",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1675",
        "device_class": "2"
      }
    }
  ]
}