FDASeptember 25, 2020device
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to false positive results.
What to do
FDA enforcement status: Terminated
Brands named
quidel
UPCs
014613339082
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAQuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.2026-04-06
- FDAQuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC2025-06-17
- FDABrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxin is a widely prescribed c...2024-12-05
- FDABrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxin is a widely prescribed c...2024-12-05
- FDAQUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests2024-03-05
- FDAQUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests2024-03-05
- FDAThe 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 t...2024-01-03
- FDAQuidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.2023-05-25
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