More than 2M at-home COVID tests recalled due to false positive concerns | KRON4

More than 2M at-home COVID tests recalled due to false positive concerns | KRON4
"SAN FRANCISCO, Calif. (KRON) — Ellume is recalling its at-home COVID-19 test due to the potential of false positive results, the U.S. Food and Drug Administration said.

• The FDA classified the recall as a Class I recall — the most serious type of recall, and says use of these tests may cause serious health consequences or death.
• The at-home test was recalled for the potential for false positive results due to a manufacturing issue.
• A false positive results shows that a person has the virus when they don’t actually have it...Read all.