{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "190680",
      "product_res_number": "Z-0462-2022",
      "event_date_initiated": "2021-12-06",
      "event_date_created": "2022-01-06",
      "recall_status": "Open, Classified",
      "res_event_number": "89168",
      "product_code": "MZP",
      "product_description": "Alinity m System, Part No. 08N53-002",
      "code_info": "Alinity m System, Model 08N53-002, all serial numbers",
      "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\n224-361-7619",
      "reason_for_recall": "There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.",
      "root_cause_description": "Software design",
      "action": "On December 06, 2021 Abbott Molecular issued a Product Recall letter to all customers who received an Alinity m instrument (List Number 08N53 002).\n\nCustomers are instructed to follow the Necessary Actions outlined in the Customer Letter\nuntil an Abbott Molecular representative adjusts the amplification detection clamp height on the Alinity m System.  Abbott personnel will follow up with customers by e mailing and or follow up visits/phone calls.",
      "product_quantity": "742 devices",
      "distribution_pattern": "Worldwide distribution - US distribution and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam",
      "openfda": {
        "k_number": [
          "K233352",
          "K252484",
          "K221007",
          "K252102"
        ],
        "pma_number": [
          "P020022",
          "P060030",
          "P000012",
          "P190025",
          "P150015",
          "P020011",
          "P000010",
          "P160023",
          "P100017"
        ],
        "registration_number": [
          "3004141078",
          "3005248192",
          "3019837962",
          "2032600",
          "2024800",
          "3025663244",
          "2243471",
          "3003795116",
          "9610126"
        ],
        "fei_number": [
          "3004141078",
          "3005248192",
          "3019837962",
          "2024800",
          "3025663244",
          "2243471",
          "3002806559",
          "3003795116",
          "3003460312"
        ],
        "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"
      }
    }
  ]
}