{
  "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,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "197382",
      "product_res_number": "Z-1009-2023",
      "event_date_initiated": "2022-12-09",
      "event_date_posted": "2023-01-20",
      "recall_status": "Open, Classified",
      "res_event_number": "91286",
      "product_code": "OOI",
      "pma_numbers": [
        "P190025"
      ],
      "product_description": "Alinity m System.  \n\nThe Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.",
      "code_info": "Model Number: 08N53-002",
      "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 firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1.  Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration.  2.  Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration.  3.  Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On December 09, 2022, Abbott Molecular issued a Field Correction Recall/Urgent Field Safety Notice to all customers who have the Alinity m System by FedEx priority overnight express.  The letter explained the problems and provided the following information:  \n\"An assessment of your Alinity m System associated with the above listed potential issues will be completed remotely if your system is currently connected to AbbottLink or alternatively via onsite inspection by an Abbott representative.  If necessary, an Abbott representative will schedule time to corrected the affected ADU9s) on your Alinity m System(s).  In the interim, please continue to follow your laboratory protocols for any suspected incorrect results.  Following the assessment and any necessary service, an additional communication will follow.  \n\nIf it is determined that your instrument was impacted, please assess the impact to your laboratory in reviewing previously generated test results.  \nThis recall is to be carried out at the user/customer level.  If this product has been further distributed by your facility, please notify any additional impacted customers.  \n\nPlease review this information with laboratory personnel and retain this communication for future reference.  If you have any questions regarding the communication, please contact your local Abbott representative, or call Abbott Technical Support at 1-800-553-7042 Option 2.\"",
      "product_quantity": "918 units",
      "distribution_pattern": "x",
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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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    }
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