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
- Company
- Quidel Corporation
- Recall Initiated
- August 13, 2021
- Terminated
- November 2, 2023
- Recall Number
- Z-2477-2021
- Quantity
- 81,910 kits
- Firm Location
- Athens, OH
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide distribution including Puerto Rico and the countries of Canada, Panama, Virgin Islands, Germany, Honduras.
Lot / Code Info
All lots
Root Cause
Under Investigation by firm
Action Taken
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 customernotifications@quidel.com. 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 technicalsupport@quidel.com or by calling 800.874.1517, Monday through Friday, 8:00 a.m. to 5:00 p.m. EST.