Bellevue, WA, United States
GS Biomark LLC recalls
1 recall recorded since 2018, most recently on 8 August 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 8 August 2022
- Reason
- Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
- Distribution
- U.S.: TX, NY, GA, IN, MD, CA, PA, MD, DC, NJ, OR, WA O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0324-2023
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.