{
  "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": "195315",
      "product_res_number": "Z-1518-2022",
      "event_date_initiated": "2022-07-19",
      "event_date_created": "2022-08-12",
      "recall_status": "Completed",
      "res_event_number": "90651",
      "product_code": "MZP",
      "pma_numbers": [
        "P190025"
      ],
      "product_description": "The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.",
      "code_info": "Serial Number 00654",
      "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": "Raymond Bastian\n224-361-7000",
      "reason_for_recall": "Incorrect optical calibration",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The recalling firm issued a letter dated 7/19/2022 via Abbott representative delivery on 7/19/2022 confirming the issue the customer had with their instrument.  The letter also said the impacted ADU4 module was taken out of service on 1/25/2022 and was then replaced with a new module on 3/22/2022.  The letter discussed the potential impact and the necessary actions to take which included completing and returning the Customer Reply Form and reviewing this information with laboratory personnel and retain the communication for future reference.",
      "product_quantity": "1",
      "distribution_pattern": "There was only foreign distribution to Italy.",
      "openfda": {
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        "device_name": "Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3170",
        "device_class": "2"
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