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Quidel Corporation

10 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp. recall (Z-2169-2026)Quidel Corporation2026-05-12
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC recall (Z-2545-2025)Quidel Corporation2025-09-10
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests recall (Z-1636-2024)Quidel Corporation2024-04-24
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests recall (Z-1637-2024)Quidel Corporation2024-04-24
The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich des recall (Z-1086-2024)Quidel Corporation2024-02-14
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein recall (Z-1308-2023)Quidel Corporation2023-03-30
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent recall (Z-1928-2021)Quidel Corporation2021-06-26
Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each pack recall (Z-1231-2017)Quidel Corporation2017-02-22
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic. recall (Z-0819-2013)Quidel Corporation2013-02-14
QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842 recall (Z-1457-2011)Quidel Corporation2011-03-01

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Every clearance here is in the API, with alerts when new ones post.