{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "27242",
      "product_res_number": "Z-0873-03",
      "event_date_initiated": "2003-04-21",
      "event_date_posted": "2003-05-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2003-07-31",
      "res_event_number": "26195",
      "product_code": "LTJ",
      "pma_numbers": [
        "P000021"
      ],
      "product_description": "Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.",
      "code_info": "Product code number RF451. Lot number CD4085 exp 3/25/04",
      "firm_fei_number": "2517506",
      "recalling_firm": "Dade Behring Inc",
      "address_1": "Rte 896, Glasgow Business Community Rte 896 Glasgow Business Community",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19702",
      "additional_info_contact": "Robin Norris\n302-631-6000",
      "reason_for_recall": "test results may be inaccurate by 0.2 to 0.5 ng/mL",
      "root_cause_description": "Other",
      "action": "The recalling firm telephone each customer on 4/24-28/03 to determine if any customer used the lot (CD4085). If so, the customer was instructed to retest all samples with an alternate lot. All customers were instructed to discard any remaining inventory. As a follow up to the phone calls, the recalling firm issued a recall letter dated 4/25/03 informing the customer of the problem and to discard any remaining product.",
      "product_quantity": "662 cartons",
      "distribution_pattern": "The product was shipped to hospitals and clinic laboratories nationwide. There are eight government/military accounts; one of which is foreign.",
      "openfda": {
        "k_number": [
          "K022177",
          "K980376",
          "K994221",
          "K973101",
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        "fei_number": [
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        ],
        "device_name": "Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.6010",
        "device_class": "2"
      }
    }
  ]
}