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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Affected units
- 10
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
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