DRG:HYBRiD-XL Insulin Device Recalled for Calibration Failures
DRG International is recalling the DRG:HYBRiD-XL Insulin device (Model HYE-5361) due to calibration failures and out-of-specification controls that may delay assay results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves a diagnostic device with calibration and control specification failures. No patient illnesses or injuries have been reported. The stated consequence is delay in test results, which constitutes a precautionary operational issue rather than demonstrated safety harm.
Plain-English summary
DRG International, Inc. is recalling the DRG:HYBRiD-XL Insulin device, Model HYE-5361, Lot Number 429K084-1. This is a medical device used in laboratory settings for insulin assays.
The device may experience calibration failures during re-calibration using the instrument's R1 and R2 calibration controls. Users may receive a failure message during re-calibration, or they may observe that control levels fall out of specification—specifically, the Control High fails. These issues cause a delay in obtaining assay results.
The affected device has been distributed nationwide in New Jersey and internationally in Czechia and Romania.
Users of the DRG:HYBRiD-XL Insulin device with Lot Number 429K084-1 should contact DRG International, Inc. for instructions regarding the recalled device.
The recalled product
- Product
- DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
- Manufacturer
- DRG International, Inc.
- Hazard
- calibration-failure
- out-of-specification-controls
- assay-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1
Distribution
Distributed nationwide across the United States.
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