Class II — Potential Health Hazard

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

NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip Recalled by NeuMoDx Molecular Inc Due to There is a potential for reduced analytical sensitivity...

Date: May 13, 2022
Company: NeuMoDx Molecular 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 NeuMoDx Molecular Inc directly.

Affected Products

NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900

Quantity: 459 kits US; 1626 kits OUS

Why Was This Recalled?

There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.

Where Was This Sold?

This product was distributed to 10 states: DE, FL, ID, MD, MI, NM, NY, PA, TN, VA

Affected (10 states)Not affected

About NeuMoDx Molecular Inc

NeuMoDx Molecular Inc has 6 total recalls tracked by RecallDetector.

Related Recalls

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