Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Recalled by Microbiologics Inc Due to The RSV target may give a late Ct...

Date: February 20, 2025
Company: Microbiologics Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Microbiologics Inc directly.

Affected Products

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

Quantity: 28 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Microbiologics Inc

Microbiologics Inc has 66 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report