Quidel Recalls COVID-19 Test Due to Risk of False Negatives

San Diego, Calif.-based diagnostics manufacturer Quidel is recalling certain batches of its Lyra SARS-CoV-2 tests because they may return false negative results.

Quidel said it is recalling the kits due to a risk of false negative results for patients with relatively high amounts of the SARS‐CoV‐2 virus that causes COVID-19.

The recall includes 43 lots of the assay distributed between March 17, 2020, and May 27, 2021. The company has received five complaints about the kits, although there have been no reports of injuries or death relating to false negative results.