{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "65375",
      "product_res_number": "Z-0299-2008",
      "event_date_initiated": "2007-09-18",
      "event_date_posted": "2008-01-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-11-05",
      "res_event_number": "45397",
      "product_code": "LOJ",
      "pma_numbers": [
        "P820060"
      ],
      "product_description": "ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version 24.0; for use on the ARCHITECT i System; List Number (LN) 6E59,Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA",
      "code_info": "LIst 6E59, Versions 22.0 and below, Assay CD-ROM Lot Numbers: 34664P100, 34708P100, 49130P100, 49131P100, 50450P100, 54701P100, 50449P100, 52151P100, 54692P100",
      "firm_fei_number": "1415939",
      "recalling_firm": "Abbott Laboratories",
      "address_1": "100 Abbott Park Rd",
      "city": "Abbott Park",
      "state": "IL",
      "postal_code": "60064-3502",
      "additional_info_contact": "Abbott Customer Suppor\n877-422-2688",
      "reason_for_recall": "The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/mL) for the ARCHITECT AFP assay file for the ARCHITECT AFP non-U.S. product.  The assay labeling indicates that the limit flag should be set no lower than 20 ng/mL",
      "root_cause_description": "Software design",
      "action": "Abbott affiliates were e-mailed copies of the Product Correction (Immediate Action Required) Recall Letter on 9/18/07 for translation where needed and dissemination to their ARCHITECT accounts who have the affected assay CD-ROMs.  Each Abbott international organization will be responsible for contacting customers and determining the method of effectiveness checks based on their country requirements.  Abbott sent Product Correction, Immediate Action Required letters dated 18 September 2007 to all active non-U.S. ARCHITECT customers who have the affected assay CD-ROMs.  The end users were informed that current AFP file has been updated on a new ARCHITECT I Assay CD-ROM (LN 6E59, version 24).  The Low-Linearity flag threshold for the Amino 1:50 dilution has changed from 15 ng/mL to 20 ng/mL for consistency with overall assay sensitivity. The accounts were advised to install the updated version of the current ARCHITECT AFP assay when they receive the version 24 ARCHITECT I Assay CD-ROM.  The accounts were requested to keep a copy of the letter on file. The accounts were requested to complete the customer reply form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for Architect testing, and fax it to Abbott by 9/28/07 at 1-800-777-0051.",
      "product_quantity": "2,490",
      "distribution_pattern": "International Only: Australia, Canada, Chile, Costa Rica, Dominican Republic, Germany, Guatemala, Honduras, Hong Kong, Jamaica, Japan, Mexico, New Zealand, Peru, Singapore, South Korea,  Thailand, Uruguay and  Venezuela. There were no USA accounts.",
      "openfda": {
        "k_number": [
          "K080017",
          "K081709",
          "K973351",
          "K851891",
          "K983031",
          "K220176",
          "K020807",
          "K981282",
          "K071597",
          "K983263",
          "K090236",
          "K023894",
          "K020806",
          "K981354",
          "K213626",
          "K972462",
          "K990138"
        ],
        "pma_number": [
          "P860044",
          "P840035",
          "P820060"
        ],
        "registration_number": [
          "",
          "3002806944",
          "2517506",
          "2032364",
          "2432235",
          "9612316",
          "1219913",
          "1036362",
          "2032839",
          "3006198300",
          "1319681",
          "3007111389",
          "9610126",
          "2246703",
          "3005529799",
          "8031673"
        ],
        "fei_number": [
          "",
          "3004185580",
          "3002808328",
          "3002806944",
          "3002806559",
          "2517506",
          "2432235",
          "3005529799",
          "1219913",
          "1036362",
          "1000136573",
          "3006198300",
          "3007111389",
          "3003323921",
          "2967",
          "2246703"
        ],
        "device_name": "Kit, Test,Alpha-Fetoprotein For Testicular Cancer",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.6010",
        "device_class": "2"
      }
    }
  ]
}