FDA recall Z-1454-2025

Microbiologics Inc · Class II · device

Product

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

Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.

Key facts

Status
Ongoing
Initiation date
2025-02-20
Report date
2025-04-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Cloud, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1454-2025