Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent Recalled by Quidel Corporation Due to In rare situations patients infected with high viral...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Quidel Corporation directly.
Affected Products
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Quantity: 29,787 kits (96 results/kit)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Quidel Corporation
Quidel Corporation has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report