{
  "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": "210150",
      "product_res_number": "Z-0138-2025",
      "event_date_initiated": "2024-09-17",
      "event_date_posted": "2024-10-22",
      "recall_status": "Open, Classified",
      "res_event_number": "95410",
      "product_code": "JJW",
      "k_numbers": [
        "K874890"
      ],
      "product_description": "Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2\n6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.",
      "code_info": "UDI-DI: 896863002134",
      "firm_fei_number": "3004386693",
      "recalling_firm": "Mckesson Medical-Surgical Inc. Corporate Office",
      "address_1": "9954 Maryland Drive Deep Run Iii",
      "address_2": "Ste. 4000",
      "city": "Richmond",
      "state": "VA",
      "postal_code": "23233",
      "additional_info_contact": "Randy King \n804-477-2825",
      "reason_for_recall": "The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25C. This may lead to delay in patients' results.",
      "root_cause_description": "Packaging process control",
      "action": "McKesson issued Urgent Product Recall letter via FedEx Overnight service scheduled for delivery on 9/17/24 to one consignee.\nLetter states reason for recall, health risk and action to take:\n1. Immediately examine your inventory and quarantine all product subject to this\nurgent product recall detailed in the affected products list (Attachment #1).\n2. Please complete, sign, and return the enclosed response form (Attachment #2 -\nCustomer Response Form) as soon as possible, even if you do not have any product\non hand. Return completed signed form MMSQARecalls@McKesson.com.\n3. If you have any product, destroy using your local procedures and document the\ndestruction on attached customer response form (Attachment #2 - Customer\nResponse Form). Return completed signed form MMSQARecalls@McKesson.com.\n4. If you have further distributed this product, please notify them immediately of this\nurgent product recall. You are encouraged to include a copy of this notification letter\nin your communication.\nIf you have questions regarding this notification, please contact McKesson MedicalSurgical directly by phone at (800) 688-8840. Representatives are available Monday -Friday, 8:00 am - 5:00 pm.",
      "product_quantity": "1 BOX",
      "distribution_pattern": "US Nationwide distribution in the state of DC.",
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        "device_name": "Urinalysis Controls (Assayed And Unassayed)",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1660",
        "device_class": "1"
      }
    }
  ]
}