BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1928-2021 · Initiated April 27, 2021

    Recall

    Recall Number
    Z-1928-2021
    Event Number
    87996
    Firm
    Quidel Corporation
    FEI Number
    1000122536
    Product Code
    QJR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 27, 2021
    Posted
    June 26, 2021
    Terminated
    September 8, 2022
    Address
    2005 E State St, Ste 100, Athens, OH, 45701-2125

    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.

    Action

    On May 13, 2021, Quidel issued an Urgent Medical Device Correction notice to customers via email notifying them that Quidel has determined that there is a potential for patients with high SARS CoV 2 viral loads to be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5 when using specified applications. YOU NEED TO TAKE THE FOLLOWING ACTIONS: 1. Immediately review the revised Lyra SARS CoV 2 Assay Instructions for Use (IFU) for updated Result Interpretation guidance: https://www.fda.gov/media/136820/download. 2. For clinical specimens generating Ct values d5, perform 1:10 and 1:100 dilutions using uninoculated transport media, extract, and test the diluted samples according to the Lyra SARS CoV 2 IFU. Refer to the Lyra SARS CoV 2 Assay IFU for full, detailed instructions. 3. It is recommended that any data which has been previously generated be re-evaluated and samples re-tested, as needed. 4. Complete the enclosed Field Corrective Action Fax Back form acknowledging receipt and understanding of the recommended actions. Return to Quidel Technical Support via fax at 858.203.9297 or via email to [email protected].

    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)