Z-1371-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2025
- Initiation Date
- February 20, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Reason for Recall
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Distribution Pattern
US Nationwide distribution in the states of TX. UK.
Code Information
UDI-DI: 10845357043563; Lot Number: HE0065-29