Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider

Revised Instructions for Use: Potential for specimens from 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 the Thermo Fisher QuantStudio 7 Pro, the Applied Biosystems 7500 Fast Dx, the Applied Biosystems 7500, the Bio-Rad CFX96 Touch", the Roche LightCycler LC 480 II/ cobas z 480, or the Qiagen Rotor-Gene MDx.

Quidel issued Urgent Medical Device Correction letter on August 13, 2021. Letter states reason for recall, health risk and action to take: For samples generating a Ct value between 0 (Undetermined) and 5, perform 1:10 and 1:100 dilutions using uninoculated Process Buffer. Process (including the heat step) and test the diluted samples according to the instructions above. Interpret the results according to Table 5 above. Note that if review of the original amplification curve from the neat sample is not suggestive of a positive result, processing of the diluted specimens may be deferred. If the diluted samples generate Ct values between 0 (Undetermined) and 5, please contact a Quidel Representative at (800) 874-1517 (toll-free in the U.S.) or (858) 552-1100 (outside of U.S.), Monday through Friday, between 8:00 a.m. and 5:00 p.m., Eastern for additional instructions. 1. Immediately review the revised Lyra Direct SARS-CoV-2 Assay Instructions for Use (IFU) for updated Result Interpretation guidance: https://www.fda.gov/media/138178/download 2. For clinical specimens generating Ct values <5, perform 1:10 and 1:100 dilutions using uninoculated Process Buffer. Process (including the heat step) and test the diluted samples according to the Lyra Direct SARS-CoV-2 IFU. Refer to the Lyra Direct 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 Filed 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]. Representatives are available to assist you in this process and answer any questions you may have about this recall. Please contact Quidel Technical Support at [email protected] or by calling 800.874.1517, Monday through Friday, 8:00 a.m. to 5:00 p.m. EST.