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 Cartridge Recalled by NeuMoDx Molecular Inc Due to There is a potential for false positive results...

Date: May 4, 2021
Company: NeuMoDx Molecular Inc
Status: Terminated
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 Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100

Quantity: 620 cases (29,760 cartridges total)

Why Was This Recalled?

There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.

Where Was This Sold?

Worldwide distribution.

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