Microbiologics Inc recalls Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality contro…

Recall date

February 20, 2025

Source

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

Recall number

Z-1371-2025

FDA classification

Class II

Brand / firm

Microbiologics Inc

Sold / distributed

US Nationwide distribution in the states of TX. UK.

Why it was recalled

The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.

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 SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N