{
  "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": "92430",
      "product_res_number": "Z-0429-2011",
      "event_date_initiated": "2010-03-15",
      "event_date_posted": "2010-11-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-01-11",
      "res_event_number": "56017",
      "product_code": "NOE",
      "product_description": "diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San Francisco, CA; Model Part Number: 90123\nThe diaDexusPLAC Test ELISA Kit is an enzyme Immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma and serum, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary hear disease, and ischemic stroke associated with atherosclerosis.",
      "code_info": "Lot Number: 907090; Part Number: 90123; Product Code NOE",
      "firm_fei_number": "3003643666",
      "recalling_firm": "DiaDexus, Inc",
      "address_1": "343 Oyster Point Blvd",
      "city": "South San Francisco",
      "state": "CA",
      "postal_code": "94080",
      "additional_info_contact": "650-246-6477",
      "reason_for_recall": "The reason for the recall is that Real Time Stability Test program showed the kit lot failed stability prior to expiration, affecting samples with results> 500 ng/ml.  Results up to 500 ng/ml exhibit passing stability results and are not impacted by this issue.",
      "root_cause_description": "Other",
      "action": "DiaDexus notified all customers by phone, including distributor's customers, beginning on March 15, 2010.  Customers were told to re-test samples that were tested from 2/1/2010 through 2/28/2010 which have values above 500 ng/ml with a new lot of product.\nFor questions regarding this recall call (650) 246-6477.",
      "product_quantity": "239 kits",
      "distribution_pattern": "Nationwide Distribution - US including NJ, OH, KS, IN, FL, CA, UT, OK, PA, WA and MI.",
      "openfda": {
        "k_number": [
          "K040101",
          "K030477",
          "K203136",
          "K101853",
          "K062234",
          "K072599",
          "K050523",
          "K141575"
        ],
        "device_name": "Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5600",
        "device_class": "2",
        "registration_number": [
          "2032900"
        ],
        "fei_number": [
          "3004445302"
        ]
      }
    }
  ]
}