FDA Enforcement
Class II
Ongoing
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
Recall: Z-1454-2025
·
Reported April 2, 2025
Enforcement
- Recall Number
- Z-1454-2025
- Event ID
- 96381
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Microbiologics Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 2, 2025
- Initiation Date
- February 20, 2025
- Classification Date
- March 25, 2025
- Address
- 200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States
Description
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
Reason
The RSV target may give a late Ct value and could potentially not pass QC.
Code Info
UDI-DI: 10845357042184; Lot Number: HE0044-131
Distribution
Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.
Quantity
28 units