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Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Mult...

FDA Recall #Z-1454-2025 — Class II — February 20, 2025

Recall #Z-1454-2025 Date: February 20, 2025 Classification: Class II Status: Ongoing

Product Description

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.

Recalling Firm

Microbiologics Inc — Saint Cloud, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

28 units

Distribution

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

Code Information

UDI-DI: 10845357042184; Lot Number: HE0044-131

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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