# FDA recall Z-1594-2023

> **SD Biosensor, Inc.** · Class I · device recall initiated 2023-03-31.

## Product

Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)

## Reason for recall

The liquid buffer component in the affected test kit lots was determined to have bacterial contamination.  User may notice a slight odor when the buffer is brought close to the nose.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** Z-1594-2023
- **Recalling firm:** SD Biosensor, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-31
- **Report date:** 2023-05-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Suwon, N/A, Korea (the Republic of)

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1594-2023

## Citation

> AI Analytics. FDA recall Z-1594-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1594-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*