# FDA recall Z-0929-2023

> **Universal Meditech Inc.** · Class I · device recall initiated 2022-11-28.

## Product

Products are labeled as:    Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT      Green and white box under the brand DiagnosUS,     and,     White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT  MADE IN USA  ORAL SWAB TESTING

## Reason for recall

Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.

## Distribution

U.S. Nationwide distribution in the states of CA, and TX.

## Key facts

- **Recall number:** Z-0929-2023
- **Recalling firm:** Universal Meditech Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-28
- **Report date:** 2023-02-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fresno, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0929-2023

## Citation

> AI Analytics. FDA recall Z-0929-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0929-2023. Source: US FDA. Licensed CC0.

---

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