FDA-Device2021-07-07Class I
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Quidel Corporation
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.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AL, CA, CT, DC, FL, ID, IN, MA, MI, MO, NM, NY, OH, SC, TN, TX, WA and the countries of Canada, Saudi Arabia, United Kingdom.
Affected count
29,787 kits (96 results/kit)
Manufactured in
2005 E State St Ste 100, N/A, Athens, OH, United States
Products
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1928-2021Don't want to check this manually?
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