Class III — Low Risk

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

ADVIA Centaur CP Immunoassay System Recalled by Siemens Healthcare Diagnostics, Inc. Due to The firm identified an issue in sample processing...

Date: March 30, 2016
Company: Siemens Healthcare Diagnostics, 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 Siemens Healthcare Diagnostics, Inc. directly.

Affected Products

ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.

Quantity: US: 442 units; Foreign: 3237 units

Why Was This Recalled?

The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.

Related Recalls

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