Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

cobas p 501 post-analytical units Recalled by Roche Diagnostics Corporation Due to There is a potential for the tray input...

Date: April 4, 2019
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 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.

Quantity: 4 units

Why Was This Recalled?

There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.

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