Class II

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

DRG International, Inc. · October 7, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

10 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0921-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.