{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "194597",
      "product_res_number": "Z-1454-2022",
      "event_date_initiated": "2022-06-09",
      "event_date_created": "2022-07-22",
      "recall_status": "Open, Classified",
      "res_event_number": "90499",
      "product_code": "PDJ",
      "k_numbers": [
        "K130255",
        "K140654"
      ],
      "product_description": "REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL",
      "code_info": "UDI/DI: 00380740102746/ Lots: 59588UQ04, 59868UQ05, 59900UQ06, 60138UQ07, 60237UQ08, 60535UQ08, 60698UQ09, 60880UQ10, 61066UQ11, 61246UQ01, 61250UQ01",
      "firm_fei_number": "3016438761",
      "recalling_firm": "Abbott Laboratories",
      "address_1": "1915 Hurd Dr",
      "city": "Irving",
      "state": "TX",
      "postal_code": "75038",
      "additional_info_contact": "Suchin Song\n224-668-0343",
      "reason_for_recall": "There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated\nusing the ARCHITECT and Alinity c Hemoglobin A1c assay.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On June 9, 2022, Abbott issued a \"Urgent Medical Device Correction\" to affected consignees via FedEx. \n1. Immediately install the updated assay file versions listed below (as applicable for your laboratory), and manually configure the Low-Linearity value. The assay files can be obtained from www.corelaboratory.abbott\n2. For the whole blood application, manually configure the THbWB Low-Linearity to 53.8278. For the hemolysate application, manually configure the THbH Low-Linearity to 1250.\n\nFor detailed information on editing assay parameters, refer to Changing assay configuration settings, Change a linearity range in the ARCHITECT System Operations Manual, Section 2.\n\n3. Please review this letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing previously reported patient results.\n\n4. Complete and return the Customer Reply Form.\n\n5. Please retain this letter for your laboratory records.\n\n6. If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter.",
      "product_quantity": "103,316",
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      "openfda": {
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          "K142595",
          "K140654",
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        "registration_number": [
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        "fei_number": [
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        "device_name": "Hemoglobin A1c Test System",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1373",
        "device_class": "2"
      }
    }
  ]
}