{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "195435",
      "product_res_number": "Z-1660-2022",
      "event_date_initiated": "2022-07-26",
      "event_date_created": "2022-08-30",
      "recall_status": "Open, Classified",
      "res_event_number": "90692",
      "product_code": "MMI",
      "k_numbers": [
        "K041192"
      ],
      "product_description": "ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27",
      "code_info": "UDI  (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127\n \nLot lot 63718UN22",
      "firm_fei_number": "1415939",
      "recalling_firm": "Abbott Laboratories",
      "address_1": "100 Abbott Park Rd Bldg Ap8b",
      "city": "Abbott Park",
      "state": "IL",
      "postal_code": "60064-3502",
      "additional_info_contact": "Customer Service\n877-422-2688",
      "reason_for_recall": "One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On July 26, 2022, Abbott issued a Product Recall letter for this issue sent the letter via FedEx priority overnight express.  The letter provided the reason for the recall and hazard involved and requested the consignee take the following actions:\n\"\" IMMEDIATELY discontinue use of ARCHITECT STAT Troponin-I, List Number 2K41-27 lot number 63718UN22 and destroy all inventory of lot 63718UN22 according to your laboratory procedures.\n\" Please contact Customer Support to order replacement material.\n\" Please review this letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for review of previously reported patient results using lot number 63718UN22.\n\" Complete and return the Customer Reply Form.\n\" If you have forwarded the product listed above to other laboratories, please inform them of this Product Recall and provide to them a copy of this letter.\n\" Please retain this letter for your laboratory records.\"  \nQuestions regarding the information were provided the  following contact information:  \nIf you or any of the health care providers you serve have questions regarding this information, please contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week).",
      "product_quantity": "2451 kits of 100 tests",
      "distribution_pattern": "Nationwide",
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        "device_name": "Immunoassay Method, Troponin Subunit",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1215",
        "device_class": "2"
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}