Quidel Lyra SARS-CoV-2 Assay Kits Recalled for Potential False Negatives
Quidel Corporation is recalling approximately 29,787 kits of the Lyra SARS-CoV-2 Assay due to a theoretical risk that samples with very high viral loads could produce false negative results. No false negatives have been formally reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Although this is FDA Class I (typically Severe or higher), the source explicitly states no false negative results have been reported, and the hazard is theoretical. Per the severity rubric, when no incidents are documented and the hazard is theoretical, the maximum score is High.
Plain-English summary
Quidel Corporation has recalled the Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent due to a potential risk of false negative results. The recall affects approximately 29,787 kits distributed nationwide across 18 US states (Alabama, California, Connecticut, Washington DC, Florida, Idaho, Indiana, Massachusetts, Michigan, Missouri, New Mexico, New York, Ohio, South Carolina, Tennessee, Texas, and Washington) and internationally to Canada, Saudi Arabia, and the United Kingdom.
The FDA classified this as a Class I recall. In rare situations, patient samples with very high SARS-CoV-2 viral loads may generate cycle threshold (Ct) values of 5 or less. On certain thermocycler platforms, if target amplification occurs before the Ct value reaches 5, these samples could be falsely reported as negative, potentially missing an active COVID-19 infection.
Laboratories and healthcare facilities using the affected lot numbers should immediately discontinue use of the recalled kits and contact Quidel Corporation for guidance or replacement products. The manufacturer reports that no false negative results have been formally reported by users of the Lyra SARS-CoV-2 Assay, though the theoretical risk prompted the recall.
The recalled product
- Product
- Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
- Manufacturer
- Quidel Corporation
- Hazard
- false-negative-result
- diagnostic-error
Distribution
Distributed nationwide across the United States.
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