GS Biomark LLC recalls CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200…

Recall date

August 8, 2022

Source

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

Recall number

Z-0324-2023

FDA classification

Class II

Brand / firm

GS Biomark LLC

Sold / distributed

U.S.: TX, NY, GA, IN, MD, CA, PA, MD, DC, NJ, OR, WA O.U.S.: None

Why it was recalled

Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.

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

What was recalled

CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800