DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 recallZ-0921-2025 · DRG International, Inc. · initiated Oct 7, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DRG International, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
DRG International began notifying consignees on 10/07/2024 via letter. Consignees were instructed to check inventory for affected units, cease use of them, and quarantine all product. Arrange return of those units. Consignees were also instructed to notify customers if units were further distributed.
Recall details
- Recall number
- Z-0921-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 7, 2024
- Posted by the FDA
- Jan 15, 2025
- Recalling firm
- DRG International, Inc.
- Quantity
- 10 units
- Product code
- CFP
- Distribution
- Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
Product description
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Code information (models, lots, serial numbers)
UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Insulin HYE-5361DRG Instruments Gesellschaft mit beschränkter Haftung · Radioimmunoassay, Immunoreactive Insulin1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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