{
  "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": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "198834",
      "product_res_number": "Z-1349-2023",
      "event_date_initiated": "2022-11-11",
      "event_date_posted": "2023-04-06",
      "recall_status": "Open, Classified",
      "res_event_number": "91777",
      "product_code": "OOI",
      "pma_numbers": [
        "P190025"
      ],
      "product_description": "Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.",
      "code_info": "Alinity m System Serial #01015, UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002; ADU Serial #AMP05139.",
      "firm_fei_number": "3005248192",
      "recalling_firm": "Abbott Molecular, Inc.",
      "address_1": "1300 E Touhy Ave",
      "city": "Des Plaines",
      "state": "IL",
      "postal_code": "60018-3315",
      "additional_info_contact": "Ray Bastian\n224-361-7000",
      "reason_for_recall": "The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit.  After correction of the issue, the instrument was returned for use without calibration.  This would result in a potential for delay of results and incorrect results.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The field service engineer installed the missing plunger assembly in the clamp bar while at the consignee location on 11/11/2022.\n\nThe recalling firm issued the recall letter on 3/1/2023 via overnight mail to their sole consignee.  The letter explains the issue, the potential impact, and the necessary actions, which includes placing the impacted ADU out of service and contacting Abbott technical support regarding concerns about the performance of the instrument or results.  The letter is to be reviewed with the Medical Director or Laboratory Management and the consignee is to follow their laboratory protocol regarding the need for review of previously reported patient results using the affected system.  A customer reply form is enclosed with the letter to acknowledge receipt and to indicate it was disseminated to all users, understood, and implemented.\n\nIf you have any questions regarding this communication, please contact your local Abbott representative or call DVP Quality Assurance, at 224-361-7000.",
      "product_quantity": "1",
      "distribution_pattern": "US Distribution to state of:  PA, a government account.",
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        "device_name": "Real Time Nucleic Acid Amplification System",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2570",
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