BEUDAMED
    FDA Enforcement Class I Terminated

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

    Recall: Z-1928-2021 · Reported July 7, 2021

    Enforcement

    Recall Number
    Z-1928-2021
    Event ID
    87996
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Quidel Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 7, 2021
    Initiation Date
    April 27, 2021
    Classification Date
    June 25, 2021
    Termination Date
    September 8, 2022
    Address
    2005 E State St Ste 100, N/A, Athens, OH, 45701-2125, United States

    Description

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

    Reason

    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.

    Code Info

    Lot 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

    Distribution

    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.

    Quantity

    29,787 kits (96 results/kit)