DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
FDA Recall #Z-0921-2025 — Class II — October 7, 2024
Product Description
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.
Recalling Firm
DRG International, Inc. — Springfield, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
10 units
Distribution
Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
Code Information
UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated