{
  "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": "2026-09-20",
    "results": {
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      "product_res_number": "Z-0958-2023",
      "event_date_initiated": "2022-11-24",
      "event_date_posted": "2023-01-17",
      "recall_status": "Open, Classified",
      "res_event_number": "91303",
      "product_code": "DHA",
      "k_numbers": [
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      "product_description": "Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels",
      "code_info": "UDI-DI/Lots: 00380740129026/000586790 and 000586879",
      "firm_fei_number": "3016438761",
      "recalling_firm": "Abbott Laboratories",
      "address_1": "1915 Hurd Dr",
      "city": "Irving",
      "state": "TX",
      "postal_code": "75038",
      "additional_info_contact": "972-518-6000",
      "reason_for_recall": "Reaction vessels may contain a potential contaminant that could affect their optical performance.",
      "root_cause_description": "Material/Component Contamination",
      "action": "On 11/24/22, the recalling firm phoned customers and informed them of the recall using a phone script.  On the same day, the phone call was followed by an email that restated the information in the phone script and included a Customer Reply form.  Customers were asked to discontinue use and destroy the impacted inventory according to their laboratory procedures. If customers forwarded the product to other laboratories, they were asked to inform them of this Product Recall and complete and return the Customer Reply form, which can be returned to PMS@abbott.com.  The reply form asked customers to record the number of boxes destroyed.\n\nIf you have any questions, contact QA Manager, Post Market Surveillance at 224-668-0343 or email: suchin.song@abbott.com.",
      "product_quantity": "70 cases",
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        "device_name": "System, Test, Human Chorionic Gonadotropin",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1155",
        "device_class": "2"
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}