Class II — Potential Health Hazard

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

cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical Recalled by Roche Diagnostics Corporation Due to Complaints have been received concerning questionable results on...

Date: December 18, 2017
Company: Roche Diagnostics Corporation
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 Roche Diagnostics Corporation directly.

Affected Products

cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).

Why Was This Recalled?

Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Roche Diagnostics Corporation

Roche Diagnostics Corporation has 39 total recalls tracked by RecallDetector.

Related Recalls

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