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 A risk for product contamination was identified for...

Date: January 21, 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, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.

Quantity: 102 boxes

Why Was This Recalled?

A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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