{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "210297",
      "product_res_number": "Z-0234-2025",
      "event_date_initiated": "2024-09-12",
      "event_date_posted": "2024-10-29",
      "recall_status": "Open, Classified",
      "res_event_number": "95442",
      "product_code": "QEP",
      "k_numbers": [
        "K222379"
      ],
      "product_description": "Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;",
      "code_info": "a) REF 09N17-095, UDI/DI 00884999048591; \nb) REF 09N17-090, UDI/DI 00884999047945; \nc) REF 09N17-091, UDI/DI 00884999049277\nAll Lots",
      "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": "Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.",
      "root_cause_description": "Device Design",
      "action": "Abbott issued an \"Urgent Field Safety Notice\" dated 9/11/2024 to its consignees on 09/12/2024 via FedEx priority overnight express.  The notice explained the issue, potential impact, and provided the following information:  \n\"Necessary Actions\n\"\t\tIf you experience an increased incidence of Error Code 9198 (Positive control is non-reactive) while testing the Alinity m HR HPVor Alinity m STI assay, please contact Abbott Technical Support at 1-800-553-7042 Option 2 for additional troubleshooting information.\n\"\tComplete and return the associated Customer Reply Form. If you have forwarded this product to any other laboratories, please also forward this letter and customer reply form to that laboratory.\nReview this information with laboratory personnel and retain this communication for future reference.\" \n\nIf you have any questions regarding this communication, please contact your local Abbott representative or call: 1-224-361-7000.",
      "product_quantity": "15068 units",
      "distribution_pattern": "Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA, IN, IL, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OR, PA, SC, TN, TX, VA, WA, and WI; and foreign (OUS) countries of: AUSTRIA, BELGUIM, BULGARIA, CAMBODIA, CANADA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., EL SALVADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, KAZAKHSTAN, KENYA, LUXEMBOURG, MALAWI, MALAYSIA, MONTENEGRO, MOROCCO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDIA ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TANZANIA, THAILAND, UNITED KINGDOM, AND VIETNAM.",
      "openfda": {
        "k_number": [
          "K190515",
          "K210585",
          "K230267",
          "K202977",
          "K240217",
          "K260917",
          "K190441",
          "K200436",
          "K253756",
          "K200533",
          "K191352",
          "K202408",
          "DEN180047",
          "K193081",
          "K200866",
          "K222379",
          "K243343",
          "K253759",
          "K200748",
          "K220407",
          "K251501",
          "K240197",
          "K220321",
          "K190433"
        ],
        "registration_number": [
          "3025663244",
          "3005248192",
          "2024800",
          "3017907743",
          "3012598266",
          "3004141078",
          "3002444944",
          "2436875",
          "9610126",
          "3009613136",
          "1181121",
          "1119779",
          "3003630504",
          "2243471",
          "3016838963",
          "3016608638",
          "3013019728",
          "3007420875",
          "3004530258",
          "3038610665",
          "3003795116",
          "3019837962",
          "3010749841"
        ],
        "fei_number": [
          "3002806559",
          "3025663244",
          "3005248192",
          "2024800",
          "3017907743",
          "3012598266",
          "1000521444",
          "3004141078",
          "3002444944",
          "3009613136",
          "1181121",
          "1119779",
          "3002468842",
          "2243471",
          "3016838963",
          "3016608638",
          "3013019728",
          "3007420875",
          "3004530258",
          "3038610665",
          "3003795116",
          "3019837962",
          "3010749841"
        ],
        "device_name": "Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3393",
        "device_class": "2"
      }
    }
  ]
}