VEO DIAGNOSTICS, LLC recalls ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081…

Recall date

November 5, 2020

Source

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

Recall number

Z-0510-2021

FDA classification

Class II

Brand / firm

VEO DIAGNOSTICS, LLC

Sold / distributed

US Nationwide distribution including in the states of IA, PA, WA.

Why it was recalled

Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests

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

What was recalled

ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021