Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200 Recalled by GS Biomark LLC Due to Distribution of COVID Test Kits without FDA Approval,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GS Biomark LLC directly.
Affected Products
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
Quantity: 639,200 kits
Why Was This Recalled?
Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
Where Was This Sold?
This product was distributed to 11 states: CA, GA, IN, MD, NJ, NY, OR, PA, TX, WA, DC
About GS Biomark LLC
GS Biomark LLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report