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# Quidel Lyra Covid Assay Recall for False Negative Risk is Class 1: FDA
- URL: https://www.fdaweb.com/quidel-lyra-covid-assay-recall-for-false-negative-risk-is-class-1-fda/
- Published: 2021-07-08T12:00:00.000Z
- Updated: 2026-09-14T17:05:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149670

FDA says a Quidel 4/26 recall of specified lots of its Lyra SARS-CoV-2 assay due to a significant risk of false-negative results for patients with relatively high amounts of SARS-CoV-2 virus potentially causing the PCR (polymerase chain reaction) amplification to occur before a cycle-threshold value of ≥ 5 when using specified thermocyclers is Class 1\. An agency [notice](https://www.fda.gov/medical-devices/medical-device-recalls/quidel-recalls-lyra-sars-cov-2-assay-m120-due-risk-false-negative-results?ref=fdaweb.com) says the lots were manufactured between 3/17/20 and 3/12/21 and distributed between 3/17/20 and 5/27/21\. The firm’s recall covers 18,385 kits that each contain 96 reactions.

“False-negative results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2 that may cause patient harm, serious illness, and death,” FDA says. “False-negative results can also lead to further spread of the SARS-CoV-2 virus when presumed negative patients are introduced into groups within healthcare, 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.”

The agency says Quidel has received five complaints about the assay, with no reports of injuries or deaths associated with the issue.