COVID-19 Assay’s False-Negative Results Culminate In Class I Recall Designation From FDA
Executive Summary
A recall of the Lyra SARS-CoV-2 Assay (M120) made by Quidel has been labeled as high risk by the US agency.
Topics
- Subjects
- Recalls
- Safety
- FDA
- Coronavirus COVID-19
- Quality
- Device Areas
- Diagnostics
- Quality Control
- Industries
- Medical Device
- Regions
- North America
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MT144179
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