Quidel Corporation
Quidel Corporation holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2024, with 14 FDA device recalls on record.
Top product codes for Quidel Corporation
FDA recalls by Quidel Corporation
10 most recent of 14- Z-2169-2026 — QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
- Z-2545-2025 — QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
- Z-1637-2024 — QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
- Z-1636-2024 — QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
- Z-1086-2024 — The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses.
- Z-1308-2023 — MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
- Z-2477-2021 — Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider
- Z-1928-2021 — Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
- Z-0428-2021 — QUIDEL Sofia SARS Antigen FIA IVD REF 20374
- Z-0124-2021 — Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Quidel Corporation
- K231795 — QuickVue COVID-19 Test
- K232286 — Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
- K233688 — Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
- K230349 — Lyra RSV+hMPV Assay
- DEN220039 — Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
- K230236 — Lyra Influenza A+B Assay
- K211342 — Sofia 2 Campylobacter FIA
- K173496 — Sofia 2 Lyme FIA, Sofia Lyme Control Set
- K181029 — Solana Bordetella Complete Assay
- K173691 — Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
- K180288 — QuickVue Influenza A+B
- K171976 — Sofia Strep A+ FIA, Sofia 2 Analyzer
- K173250 — Solana GBS Assay
- K163713 — Sofia Lyme FIA, Sofia Lyme Control Set
- K171974 — Solana RSV+hMPV Assay
- K170491 — Solana C. difficile Assay
- K162438 — Sofia Influenza A+B FIA on Sofia 2
- K162911 — Sofia RSV FIA on Sofia 2 analyzer
- K162451 — Solana HSV 1+2/VZV Assay
- K162274 — Solana Strep Complete Assay
- K161814 — Solana Influenza A+B Assay
- K161182 — Solana Trichomonas Assay
- K153012 — Sofia Influenza A+B FIA
- K150868 — Solana GAS Assay, Solana instrument
- K143329 — AmpliVue Trichomonas Assay
- K141775 — SOFIA (R) STREP A+ FIA
- K143206 — AmpliVue Bordetella Assay
- K141927 — LYRA PARAINFLUENZA VIRUS ASSAY
- K141931 — LYRA ADENOVIRUS ASSAY
- K141173 — AMPLIVUE GAS ASSAY
- DEN140005 — LYRA DIRECT STREP ASSAY
- K140029 — AMIPLIVUE HSV 1&2 ASSAY
- K133503 — AMPLIVUE GBS ASSAY
- K131599 — QUICK VUE INFLUENZA
- K123793 — SOFIA STREP A FIA
- K123355 — AMPLIVUE C. DIFFICILE ASSAY
- K102175 — RAPIDVUE HCG TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.