Device product
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Z-1371-2025
Product summary
- Event
- Event 96382
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-1371-2025
Official wording
Reason: The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Code information: UDI-DI: 10845357043563; Lot Number: HE0065-29
Distribution pattern: US Nationwide distribution in the states of TX. UK.
Derived failure modes
-
Unknown
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.