FDA Enforcement
Class II
Ongoing
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Recall: Z-0921-2025
·
Reported January 22, 2025
Enforcement
- Recall Number
- Z-0921-2025
- Event ID
- 95785
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- DRG International, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 22, 2025
- Initiation Date
- October 7, 2024
- Classification Date
- January 15, 2025
- Address
- 841 Mountain Ave, Springfield, NJ, 07081-3437, United States
Description
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Reason
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.
Code Info
UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1
Distribution
Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
Quantity
10 units