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DRG International, Inc. recalls DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Recalled January 22, 2025 · FDA recall Z-0921-2025 · DRG International
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. · FDA Class II
Units
10 units
Sold at
Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
Description
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.
Product
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Manufacturer(s)
DRG International, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →