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
Reported: December 7, 2022 Initiated: August 8, 2022 #Z-0324-2023
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.
Details
- Recalling Firm
- GS Biomark LLC
- Units Affected
- 639,200 kits
- Distribution
- U.S.: TX, NY, GA, IN, MD, CA, PA, MD, DC, NJ, OR, WA O.U.S.: None
- Location
- Bellevue, WA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by GS Biomark LLC. Units affected: 639,200 kits.
Why was this product recalled? ▼
Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 7, 2022. Severity: Moderate. Recall number: Z-0324-2023.
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