FDA Enforcement
Class II
Ongoing
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Recall: Z-1371-2025
·
Reported March 26, 2025
Enforcement
- Recall Number
- Z-1371-2025
- Event ID
- 96382
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Microbiologics Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 26, 2025
- Initiation Date
- February 20, 2025
- Classification Date
- March 14, 2025
- Address
- 200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States
Description
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Reason
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Code Info
UDI-DI: 10845357043563; Lot Number: HE0065-29
Distribution
US Nationwide distribution in the states of TX. UK.
Quantity
6 units