Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5. There have been no formal complaints of False Negative results with Ct values <5 from Lyra SARS-CoV-2 Assay users.
What to do
FDA enforcement status: Terminated
Brands named
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, 20 Tests2024-03-05
- FDAQUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 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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