DRG International, Inc. recalls DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
- Recall date
- October 7, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0921-2025
- FDA classification
- Class II
- Brand / firm
- DRG International, Inc.
- Sold / distributed
- Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
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