Device product
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
Z-1454-2025
Product summary
- Event
- Event 96381
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 28 units
- Official record key
device-enforcement:Z-1454-2025
Official wording
Reason: The RSV target may give a late Ct value and could potentially not pass QC.
Code information: UDI-DI: 10845357042184; Lot Number: HE0044-131
Distribution pattern: Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.
Derived failure modes
-
Unknown
The RSV target may give a late Ct value and could potentially not pass QC.