Class II — Potential Health Hazard

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

BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001 Recalled by Roche Diagnostics Operations, Inc. Due to Potential for Fluid leaks within the instruments, creating...

Date: August 31, 2020
Company: Roche Diagnostics Operations, 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 Roche Diagnostics Operations, Inc. directly.

Affected Products

BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001

Quantity: 2623 (US); 3735 (ex-US)

Why Was This Recalled?

Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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