# FDA recall Z-0324-2023

> **GS Biomark LLC** · Class II · device recall initiated 2022-08-08.

## 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

## Reason for recall

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

## Key facts

- **Recall number:** Z-0324-2023
- **Recalling firm:** GS Biomark LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-08
- **Report date:** 2022-12-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bellevue, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0324-2023

## Citation

> AI Analytics. FDA recall Z-0324-2023. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-0324-2023. Source: US FDA. Licensed CC0.

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