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

Hazard

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.

Details from the source

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. Quantity: 10 units Lot/code info: UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1

UPC codes

04048474053616

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.