Class II — Potential Health Hazard

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

VIDAS Lyme IgM II (LYM) Recalled by bioMerieux, Inc. Due to bioMerieux has been receiving an increasing number of...

Date: September 22, 2021
Company: bioMerieux, 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 bioMerieux, Inc. directly.

Affected Products

VIDAS Lyme IgM II (LYM), REF 416436

Quantity: Three lots

Why Was This Recalled?

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About bioMerieux, Inc.

bioMerieux, Inc. has 53 total recalls tracked by RecallDetector.

Related Recalls

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