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 p 612 pre-analytical system Recalled by Roche Diagnostics Corporation Due to

Date: December 27, 2016
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 p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.

Quantity: 5

Why Was This Recalled?

Where Was This Sold?

This product was distributed to 2 states: TX, WA

Affected (2 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