{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Des Plaines",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88626",
      "recalling_firm": "Abbott Molecular, Inc.",
      "address_1": "1300 E Touhy Ave",
      "address_2": "N/A",
      "postal_code": "60018-3315",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution. US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MONTENEGRO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, and VIETNAM.",
      "recall_number": "Z-0004-2022",
      "product_description": "Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File.  in vitro diagnostic",
      "product_quantity": "60563 units",
      "reason_for_recall": "There is a potential for false positive results.",
      "recall_initiation_date": "20210902",
      "center_classification_date": "20211014",
      "termination_date": "20240723",
      "report_date": "20211020",
      "code_info": "List Number: 09N78-095, UDI 00884999049222; Lot/Serial, Expiration: 511810, 09/18/2021;  512026, 09/21/2021;  512900, 10/14/2021;  513146, 10/14/2021;  513583, 11/18/2021;  513959, 11/23/2021;  514176, 11/23/2021;  514216, 12/01/2021;  514819, 12/17/2021;  515052, 01/05/2022;  515653, 01/28/2022;  515949, 02/05/2022;  516085, 02/11/2022;  516611, 02/22/2022;  517139, 03/01/2022;  517355, 03/08/2022;  517999, 03/19/2022;  518266, 03/22/2022;  518435, 03/22/2022;  522689, 09/14/2022;  518670, 04/01/2022;  522691, 09/14/2022;  519124, 05/03/2022;  523309, 09/13/2022;  519583, 05/11/2022;  523468, 09/23/2022;  519785, 05/18/2022;  523621, 10/01/2022;  519968, 05/25/2022;  523946, 10/08/2022;  520216, 06/08/2022;  524203, 10/21/2022;  520699, 06/30/2022;  524438, 10/25/2022;  521106, 07/13/2022;  525862, 12/16/2022;  521654, 07/23/2022;  526394, 12/30/2022;  521842, 07/27/2022;  526484, 01/14/2023;  521857, 07/27/2022;  527399, 01/28/2023;  527400, 01/28/2023;  527540, 02/04/2023;  528026, 02/18/2023;    List File 09N78-03E, UDI (01)00884999050211(240)09N78-03E(8012)5.oo"
    }
  ]
}