FDA MedWatch - Lyra SARS-CoV-2 Assay (M120) by Quidel

Class I Recall - Due to Risk of False Negative Results

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Lyra SARS-CoV-2 Assay (M120) by Quidel: Class I Recall - Due to Risk of False Negative Results AUDIENCE: Patient, Health Professional, Risk Manager, Laboratory ISSUE: Quidel is recalling the Lyra SARS-CoV-2 Assay (M120) due to a significant risk of false negative results for patients with relatively high amounts of SARS‐CoV‐2 virus potentially causing the PCR amplification to occur before a cycle‐threshold (Ct) value of ≤5 when using the following thermocyclers: ThermoFisher QuantStudio 7 Pro Applied Biosystems 7500 Fast Dx Applied Biosystems 7500 Bio-Rad CFX96 Touch Roche LightCycler 480 or Qiagen RotorGene MDx) False negative results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2 that may cause patient harm, serious illness, and death. False negative results can also lead to further spread of the SARS-CoV-2 virus, when presumed negative patients are introduced into groups within health care, long-term care, or other similar facilities. Actions to limit exposure based on false negative results might not be taken, such as isolating infected individuals. Quidel has received five complaints about the Lyra SARS-CoV-2 Assay (M120), however, there have been no reports of injuries or death from this issue. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The Lyra SARS-CoV-2 Assay (M120) is a real-time polymerase chain reaction (RT-PCR) assay used to qualitatively detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19.  RECOMMENDATIONS: On April 26, 2021, Quidel sent all affected customers an "Urgent: Field Corrective Action" letter by email. The letter requested customers to: Review the revised Lyra SARS CoV 2 Assay Instructions for Use (IFU) for an updated Result Interpretation guidance:  https://www.fda.gov/media/136820/download. For clinical specimens generating Ct values ≤5: Perform 1:10 and 1:100 dilutions using uninoculated transport media Extract (process) 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 and interpretation of results Re-evaluate any data that was previously generated and re-test those samples, as needed, as noted above. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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