# FDA recall Z-0602-2024

> **Zeus Scientific, Inc.** · Class II · device recall initiated 2023-10-31.

## Product

ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M

## Reason for recall

The organization completed a product improvement process to the conjugate found within the certain ELISA kits.  This modification was not reviewed and approved by FDA prior to its implementation.

## Distribution

US States: CA, MA, MI, NJ, NY, TN, UT.

## Key facts

- **Recall number:** Z-0602-2024
- **Recalling firm:** Zeus Scientific, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-31
- **Report date:** 2023-12-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Branchburg, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0602-2024

## Citation

> AI Analytics. FDA recall Z-0602-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0602-2024. Source: US FDA. Licensed CC0.

---

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