Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 Recalled by DRG International, Inc. Due to The user of the assay may either face...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DRG International, Inc. directly.
Affected Products
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Quantity: 10 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About DRG International, Inc.
DRG International, Inc. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report