{
  "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": "Athens",
      "state": "OH",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87996",
      "recalling_firm": "Quidel Corporation",
      "address_1": "2005 E State St Ste 100",
      "address_2": "N/A",
      "postal_code": "45701-2125",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, CA, CT, DC, FL, ID, IN, MA, MI, MO, NM, NY, OH, SC, TN, TX, WA and the countries of Canada, Saudi Arabia, United Kingdom.",
      "recall_number": "Z-1928-2021",
      "product_description": "Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent",
      "product_quantity": "29,787 kits (96 results/kit)",
      "reason_for_recall": "In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5. There have been no formal complaints of False Negative results with Ct values <5  from Lyra SARS-CoV-2 Assay users.",
      "recall_initiation_date": "20210427",
      "center_classification_date": "20210625",
      "termination_date": "20220908",
      "report_date": "20210707",
      "code_info": "Lot Number: 031620A  031620B  031620C  032320  032420  032720  032820A  032820B  040320  040720  040920  041020  174992  175429  175501  175502  175503  176001  176002  176366  176367  176368  178984  178985  180331  180332  180673  180674  180675  182594  184273  185535  185822  186470  186472  187062  187173  187822  189232  189942  190786  193074  193977"
    }
  ]
}