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GS Biomark LLC recalls CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK
Recalled December 7, 2022 · FDA recall Z-0324-2023 · GS Biomark
Hazard
Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization. · FDA Class II
Units
639,200 kits
Sold at
U.S.: TX, NY, GA, IN, MD, CA, PA, MD, DC, NJ, OR, WA O.U.S.: None
Description
Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
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
Manufacturer(s)
GS Biomark LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →