DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
This recall is currently active, issued January 15, 2025. It was issued by Drg International, Inc..
- Company
- Drg International, Inc.
- Recall Initiated
- October 7, 2024
- Posted
- January 15, 2025
- Recall Number
- Z-0921-2025
- Quantity
- 10 units
- Firm Location
- Springfield, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
Lot / Code Info
UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1
Root Cause
Nonconforming Material/Component
Action Taken
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.