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 c513 Analyzer Recalled by Roche Diagnostics Operations, Inc. Due to Quality issue with high pressure solenoid valves

Date: July 18, 2019
Company: Roche Diagnostics Operations, 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 Roche Diagnostics Operations, Inc. directly.

Affected Products

cobas c513 Analyzer

Quantity: 2 units

Why Was This Recalled?

Quality issue with high pressure solenoid valves

Where Was This Sold?

This product was distributed to 15 states: AK, CA, FL, HI, IN, KS, KY, LA, MD, MO, MT, NY, OH, OR, TX

Affected (15 states)Not affected

About Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc. has 127 total recalls tracked by RecallDetector.

Related Recalls

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