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Quidel Corporation Recall 87996

Description: Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent

Quidel Corporation Recall 87996 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1928-2021
Event ID87996
Event DescriptionLyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Product TypeDevices
DistributionWorldwide 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.
Quantity29,787 kits (96 results/kit)
Recall ReasonIn 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.
Device Classification20210707
Device Code InfoLot Number: 031620A 031620B 031620C 032320 032420 032720 032820A 032820B 040320 040720 040920 041020 174992 175429 175501 175502 175503 176001 176002 176366 176367 176368 178984 178985 180331 180332 180673 180674 180675 182594 184273 185535 185822 186470 186472 187062 187173 187822 189232 189942 190786 193074 193977
Center Classification Date20210625
Recall Initiation Date20210427
Recalling FirmQuidel Corporation
Initial Notification E-Mail
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