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Quidel Corporation FDA Recalls
8 recalls on file across devices, 1 of them Class I and 6 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.Class IIApr 6, 2026Product has the potential for false positive results |
| QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SCClass IIJun 17, 2025Dipstick strep A test has potential for false positive resul |
| QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 TestsClass IIMar 5, 2024There are two windows on the test device, the control line w |
| QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 TestsClass IIMar 5, 2024There are two windows on the test device, the control line w |
| The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 Class IIJan 3, 2024One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) w |
| MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, CatClass IIFeb 1, 2023Kits with affected microtiter plates have the potential to p |
| Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-timeClass IIAug 13, 2021Revised Instructions for Use: Potential for specimens from p |
| Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagentClass IApr 27, 2021In rare situations patients infected with high viral load of |