Quidel Corporation
FDA Regulatory Profile
Quidel Corporation appears in FDA public data with 14 recalls — including 1 Class I (most serious) —, 37 510(k) clearances, 8 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2169-2026, Class II) was initiated on April 6, 2026. Its most recent 510(k) clearance was granted on March 22, 2024.
Summary
- Total Recalls
- 14 (1 Class I)
- 510(k) Clearances
- 37
- Inspections
- 8
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2169-2026 | Class II | QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp. | April 6, 2026 |
| Z-2545-2025 | Class II | QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC | June 17, 2025 |
| Z-1636-2024 | Class II | QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests | March 5, 2024 |
| Z-1637-2024 | Class II | QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests | March 5, 2024 |
| Z-1086-2024 | Class II | The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that i | January 3, 2024 |
| Z-1308-2023 | Class II | MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human | February 1, 2023 |
| Z-2477-2021 | Class II | Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 | August 13, 2021 |
| Z-1928-2021 | Class I | Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent | April 27, 2021 |
| Z-0428-2021 | Class II | QUIDEL Sofia SARS Antigen FIA IVD REF 20374 | September 25, 2020 |
| Z-0124-2021 | Class II | Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluores | September 17, 2020 |
| Z-1183-2018 | Class II | Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with | December 15, 2017 |
| Z-2803-2017 | Class II | InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay | June 22, 2017 |
| Z-1231-2017 | Class II | Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package conta | January 25, 2017 |
| Z-0819-2013 | Class II | Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic. | December 3, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231795 | QuickVue COVID-19 Test | March 22, 2024 |
| K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument | December 20, 2023 |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | December 13, 2023 |
| K230349 | Lyra RSV+hMPV Assay | March 10, 2023 |
| DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | March 8, 2023 |
| K230236 | Lyra Influenza A+B Assay | March 3, 2023 |
| K211342 | Sofia 2 Campylobacter FIA | November 23, 2021 |
| K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control Set | August 30, 2018 |
| K181029 | Solana Bordetella Complete Assay | July 15, 2018 |
| K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack | February 28, 2018 |
| K180288 | QuickVue Influenza A+B | February 13, 2018 |
| K173250 | Solana GBS Assay | December 21, 2017 |
| K171976 | Sofia Strep A+ FIA, Sofia 2 Analyzer | December 21, 2017 |
| K163713 | Sofia Lyme FIA, Sofia Lyme Control Set | October 20, 2017 |
| K171974 | Solana RSV+hMPV Assay | October 16, 2017 |
| K170491 | Solana C. difficile Assay | May 11, 2017 |
| K162438 | Sofia Influenza A+B FIA on Sofia 2 | April 14, 2017 |
| K162911 | Sofia RSV FIA on Sofia 2 analyzer | February 22, 2017 |
| K162451 | Solana HSV 1+2/VZV Assay | November 28, 2016 |
| K162274 | Solana Strep Complete Assay | October 25, 2016 |