medical Class II Updated 2025-01-22

DRG International, Inc. recalls DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1
View official government recall

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