{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "196460",
      "product_res_number": "Z-0135-2023",
      "event_date_initiated": "2022-09-23",
      "event_date_posted": "2022-10-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-12-13",
      "res_event_number": "90998",
      "product_code": "QKP",
      "product_description": "LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit\nCatalog #: L016080109002 (EUA)\n\nThe LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality\ncontrol testing performed on the LumiraDx Instrument when used with\nthe LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users\nwith assurance that the device is performing within specification",
      "code_info": "LQC Kit: 2002204017\nPositive Control Vial: 1000 1710 0014 0141\nNegative Control Vial: 1000 1720 0014 0142\n\nExp. Date: 01-Mar-2023",
      "firm_fei_number": "3012642695",
      "recalling_firm": "LumiraDx",
      "address_1": "221 Crescent St",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02453-3475",
      "reason_for_recall": "Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC",
      "root_cause_description": "Error in labeling",
      "action": "LumiraDx issued Urgent Product Recall Notice and were provided with an attestation form to document product destruction at their facility via email on 23 September 2022. Letter states reason for recall, health risk and action to take:\nImmediately stop using the affected lots of LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Controls.\n\" Remove from your stock any remaining affected kits of LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Controls as listed in Table 1.\n\" Ensure any of the affected SARS-CoV-2 Antigen (Ag) Liquid Quality Controls are removed from your inventory are destroyed (not just thrown away), indicate the number of Liquid Quality Control kits that were destroyed, and sign the attestation form at the end of this notice verifying destruction of the affected SARS-CoV-2 Antigen (Ag) Liquid Quality Controls in your inventory.\n\" Report any issues or adverse events with using the LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Controls to LumiraDx immediately or to the FDA via the MedWatch program.\n\" Please forward this notice to additional testing sites if these products were further distributed within your system.\n\" LumiraDx will provide replacement product over the course of the next few days.\n\nIf you have any questions, contact LumiraDx Customer Services at customerservices.US@lumiradx.com or 1-888-586-4721.",
      "product_quantity": "83 kits",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "registration_number": [
          "",
          "3026565854",
          "3015883679",
          "3032562",
          "1221359",
          "3008517993",
          "2432235",
          "3016850770",
          "3028746593",
          "3003297763",
          "9610126",
          "3016820006",
          "3009014878",
          "3000308930",
          "2032682",
          "1000115322",
          "3020305857",
          "3010934853",
          "3024756665",
          "3033507883",
          "1313700",
          "3016610313",
          "3025041446",
          "3023372670",
          "3026664926",
          "3009963993",
          "9610240",
          "3014862351",
          "2025099",
          "3008959428",
          "2024674",
          "3003896222",
          "3004142665",
          "3016761091",
          "3013160357",
          "3028107593",
          "3017887566",
          "2250051",
          "2246703",
          "3011522054",
          "3002792284",
          "3027500452",
          "3022474803",
          "3005984081",
          "3043128348",
          "3017662853",
          "3014022295",
          "3004181896",
          "1122236",
          "2030538",
          "3014654360",
          "2029372",
          "3039321686",
          "3004146366",
          "3017171515",
          "2020808",
          "3012963943",
          "3014660585",
          "3021082896",
          "3008054239",
          "3002642396",
          "3011561946",
          "3002821211",
          "3008825965",
          "3020964039",
          "3012516456",
          "3033751096",
          "3016837106",
          "3018187017",
          "3023947183",
          "3009238284",
          "3017894300",
          "2431980",
          "3005360469",
          "3008573045",
          "3007111389",
          "1219913",
          "1319681",
          "3027518847",
          "3039322300",
          "3008925277",
          "3012133212",
          "3021090658"
        ],
        "fei_number": [
          "",
          "3026565854",
          "3015883679",
          "1221359",
          "3008517993",
          "2432235",
          "3016850770",
          "3028746593",
          "3003297763",
          "3016820006",
          "3004069780",
          "3009014878",
          "3000308930",
          "1000115322",
          "3020305857",
          "3010934853",
          "3024756665",
          "3033507883",
          "1313700",
          "3016610313",
          "3025041446",
          "3023372670",
          "3026664926",
          "3009963993",
          "3014862351",
          "3008959428",
          "2024674",
          "3004142665",
          "3016761091",
          "3013160357",
          "3028107593",
          "3017887566",
          "2250051",
          "2246703",
          "3011522054",
          "3002792284",
          "3027500452",
          "3022474803",
          "3010687142",
          "3005984081",
          "3043128348",
          "1000306617",
          "3017662853",
          "3014022295",
          "3004181896",
          "1122236",
          "3014654360",
          "3039321686",
          "3004146366",
          "3017171515",
          "2020808",
          "3012963943",
          "3014660585",
          "3021082896",
          "3003952975",
          "3008054239",
          "3002642396",
          "3011561946",
          "3002821211",
          "3005670738",
          "3008825965",
          "1000136573",
          "3020964039",
          "3012516456",
          "3002806559",
          "1000520007",
          "3033751096",
          "3016837106",
          "3018187017",
          "3023947183",
          "3009238284",
          "3017894300",
          "2431980",
          "3002808212",
          "3002606748",
          "3007981058",
          "3008573045",
          "3007111389",
          "1219913",
          "3027518847",
          "3039322300",
          "3012133212",
          "3021090658"
        ],
        "device_name": "Coronavirus Antigen Detection Test System.",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}