Z-1454-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 2, 2025
- Initiation Date
- February 20, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 units
Product Description
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
Reason for Recall
The RSV target may give a late Ct value and could potentially not pass QC.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.
Code Information
UDI-DI: 10845357042184; Lot Number: HE0044-131