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Quidel Corporation recalls Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Recalled July 7, 2021 · FDA recall Z-1928-2021 · Quidel
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. · FDA Class I
Units
29,787 kits (96 results/kit)
Sold at
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.
Description
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.
Product
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Manufacturer(s)
Quidel Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →