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Open, Classified

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

FDA Recall Z-0324-2023 · Posted 2022-11-29

Recalling FirmGS Biomark LLC
Recall StatusOpen, Classified
Product CodeQJR
Date Initiated2022-08-08
Product Quantity639,200 kits

Reason for Recall

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

Firm Action

On 08/08/2022, GS Biomark emailed customer to notify them that their COVID test kits - CoViPoint COVID test kit (MultiPLEX/Direct) have expired and to destroy unused material that they still have on-hand. Customer were not informed that the affected products did not have Emergency Use Authorization to distributed the product within the U.S.

Root Cause

No Marketing Application

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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