# FDA recall Z-0921-2025

> **DRG International, Inc.** · Class II · device recall initiated 2024-10-07.

## Product

DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

## Reason for recall

The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in results.

## Distribution

Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.

## Key facts

- **Recall number:** Z-0921-2025
- **Recalling firm:** DRG International, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-07
- **Report date:** 2025-01-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0921-2025

## Citation

> AI Analytics. FDA recall Z-0921-2025. Retrieved 2026-09-21 from https://api.ai-analytics.org/recall/Z-0921-2025. Source: US FDA. Licensed CC0.

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