{
  "companyId": "49225",
  "slug": "quidel-corporation-49225",
  "name": "Quidel Corporation",
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    "total": 128,
    "last12Months": 0,
    "first": "1983-05-18",
    "latest": "2024-03-22"
  },
  "medianReviewDays": 71,
  "productCodeCount": 36,
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      {
        "resNumber": "Z-2169-2026",
        "productCode": "GTY",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-04-06",
        "reason": "Product has the potential for false positive results"
      },
      {
        "resNumber": "Z-2545-2025",
        "productCode": "GTY",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-06-17",
        "reason": "Dipstick strep A test has potential for false positive results."
      },
      {
        "resNumber": "Z-1636-2024",
        "productCode": "PFQ",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-03-05",
        "reason": "There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result."
      },
      {
        "resNumber": "Z-1637-2024",
        "productCode": "PFQ",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-03-05",
        "reason": "There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result."
      },
      {
        "resNumber": "Z-1086-2024",
        "productCode": "QMN",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-01-03",
        "reason": "One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 31, 2025, however the correct expiration date for the pouches is September 12, 2024. The kits are labeled with an expiration date of April 30, 2025, however, the correct expiration date for the kits is September 12, 2024. The issue was discovered on November 28, 2023 by a supply chain employee who determined that the kits had expiration dates beyond the FDA authorized shelf life."
      }
    ]
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    "countries": [
      "US"
    ]
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      "code": "JHI",
      "deviceName": "Visual, Pregnancy Hcg, Prescription Use",
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    },
    {
      "code": "DHB",
      "deviceName": "System, Test, Radioallergosorbent (Rast) Immunological",
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    },
    {
      "code": "LCX",
      "deviceName": "Kit, Test, Pregnancy, Hcg, Over The Counter",
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      "latest": "1998-06-03",
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    },
    {
      "code": "GTZ",
      "deviceName": "Antisera, All Groups, Streptococcus Spp.",
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      "medianReviewDays": 62
    },
    {
      "code": "PSZ",
      "deviceName": "Devices Detecting Influenza A, B, And C Virus Antigens",
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      "latest": "2018-02-13",
      "medianReviewDays": 88
    },
    {
      "code": "LYR",
      "deviceName": "Helicobacter Pylori",
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      "medianReviewDays": 105
    },
    {
      "code": "GTY",
      "deviceName": "Antigens, All Groups, Streptococcus Spp.",
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    },
    {
      "code": "JJX",
      "deviceName": "Single (Specified) Analyte Controls (Assayed And Unassayed)",
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      "medianReviewDays": 48
    },
    {
      "code": "OCC",
      "deviceName": "Respiratory Virus Panel Nucleic Acid Assay System",
      "clearances": 5,
      "latest": "2017-10-16",
      "medianReviewDays": 88
    },
    {
      "code": "GQG",
      "deviceName": "Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus",
      "clearances": 4,
      "latest": "2017-02-22",
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    },
    {
      "code": "CEP",
      "deviceName": "Radioimmunoassay, Luteinizing Hormone",
      "clearances": 3,
      "latest": "1995-08-23",
      "medianReviewDays": 57
    },
    {
      "code": "DGC",
      "deviceName": "Ige, Antigen, Antiserum, Control",
      "clearances": 3,
      "latest": "1991-03-12",
      "medianReviewDays": 60
    },
    {
      "code": "GNX",
      "deviceName": "Antigens, Cf (Including Cf Control), Influenza Virus A, B, C",
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      "latest": "2013-07-05",
      "medianReviewDays": 32
    },
    {
      "code": "LJC",
      "deviceName": "Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)",
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      "latest": "1995-05-19",
      "medianReviewDays": 108
    },
    {
      "code": "LSR",
      "deviceName": "Reagent, Borrelia Serological Reagent",
      "clearances": 3,
      "latest": "2018-08-30",
      "medianReviewDays": 290
    },
    {
      "code": "OEM",
      "deviceName": "Human Metapneumovirus (Hmpv) Rna Assay System",
      "clearances": 3,
      "latest": "2023-03-10",
      "medianReviewDays": 108
    },
    {
      "code": "OZE",
      "deviceName": "Influenza A And Influenza B Multiplex Nucleic Acid Assay",
      "clearances": 3,
      "latest": "2023-03-03",
      "medianReviewDays": 78
    },
    {
      "code": "OZN",
      "deviceName": "C. Difficile Toxin Gene Amplification Assay",
      "clearances": 3,
      "latest": "2017-05-11",
      "medianReviewDays": 72
    },
    {
      "code": "PGX",
      "deviceName": "Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System",
      "clearances": 3,
      "latest": "2016-10-25",
      "medianReviewDays": 79
    },
    {
      "code": "KTN",
      "deviceName": "System, Test, Infectious Mononucleosis",
      "clearances": 2,
      "latest": "1990-01-26",
      "medianReviewDays": 30
    },
    {
      "code": "NJR",
      "deviceName": "Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test",
      "clearances": 2,
      "latest": "2017-12-21",
      "medianReviewDays": 36
    },
    {
      "code": "OUY",
      "deviceName": "Trichomonas Vaginalis Nucleic Acid Amplification Test System",
      "clearances": 2,
      "latest": "2016-08-15",
      "medianReviewDays": 110
    },
    {
      "code": "OZZ",
      "deviceName": "Bordetella Pertussis Dna Assay System",
      "clearances": 2,
      "latest": "2018-07-15",
      "medianReviewDays": 33
    },
    {
      "code": "PGI",
      "deviceName": "Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples",
      "clearances": 2,
      "latest": "2023-12-20",
      "medianReviewDays": 88
    },
    {
      "code": "CEN",
      "deviceName": "Dye-Indicator, Ph (Urinary, Non-Quantitative)",
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      "medianReviewDays": 118
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  ],
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  "productCodesTotal": "36",
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    {
      "kNumber": "K231795",
      "deviceName": "QuickVue COVID-19 Test",
      "productCode": "QYT",
      "decisionDate": "2024-03-22",
      "reviewDays": 276
    },
    {
      "kNumber": "K232286",
      "deviceName": "Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument",
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    {
      "kNumber": "K233688",
      "deviceName": "Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set",
      "productCode": "QVF",
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      "kNumber": "K211342",
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      "kNumber": "K173496",
      "deviceName": "Sofia 2 Lyme FIA, Sofia Lyme Control Set",
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    {
      "kNumber": "K181029",
      "deviceName": "Solana Bordetella Complete Assay",
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      "kNumber": "K173691",
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      "kNumber": "K180288",
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      "productCode": "PSZ",
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    "shown": [
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        "name": "QUIDEL CORP.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
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      {
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      {
        "name": "Quidel Corporation",
        "dataset": "device/510k",
        "method": "normalised"
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      {
        "name": "Quidel Corporation",
        "dataset": "device/enforcement",
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      {
        "name": "Quidel Corporation",
        "dataset": "device/recall",
        "method": "normalised"
      }
    ]
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  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Quidel%20Corporation%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Quidel%20Corporation%22"
  },
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      "loadedAt": "2026-08-10T19:40:09Z",
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    },
    {
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      "loadedAt": "2026-08-11T13:58:22Z",
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  "retrievedAt": "2026-08-11T14:48:53.036Z"
}