Recall Z-0324-2023— GS Biomark LLC

Name: FDA recall Z-0324-2023
Creator: U.S. Food and Drug Administration
Published: 2022-08-08

Class II · Ongoing

Class II FDA medical device recall by GS Biomark LLC, initiated 2022-08-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization..

Recalling firm: GS Biomark LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-08-08
Firm location: Bellevue, WA, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.