Class II — Potential Health Hazard

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

Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling Recalled by Roche Diagnostics Operations, Inc. Due to Possible for sample tubes in the loader to...

Date: September 22, 2015
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

Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.

Quantity: 1

Why Was This Recalled?

Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.

Where Was This Sold?

This product was distributed to 1 state: TX

Affected (1 state)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