Z-0921-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2025
- Initiation Date
- October 7, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
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 Pattern
Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
Code Information
UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1