Class II

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

Microbiologics Inc · February 20, 2025

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.

States Affected

NATIONWIDE

Quantity Affected

28 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1454-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.