LumiraDx recalls Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid p…

Recall date

February 3, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1312-2021

FDA classification

Class II

Brand / firm

LumiraDx

Sold / distributed

US nationwide distribution.

Why it was recalled

Two lots of test strips failed QC testing using blank buffer due to false positives.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset.