Microbiologics Inc recalls Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed q…

Recall date

February 20, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1454-2025

FDA classification

Class II

Brand / firm

Microbiologics Inc

Sold / distributed

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

Why it was recalled

The RSV target may give a late Ct value and could potentially not pass QC.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N