Class II — Potential Health Hazard

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

Atellica CH 930 Analyzer Recalled by Siemens Healthcare Diagnostics, Inc. Due to On the Atellica CH 930 Analyzer, when scanning...

Date: October 11, 2019
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

Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens.

Quantity: 1528

Why Was This Recalled?

On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the system will translate the decimal point separators to commas. This will result in invalid concentration values for the fluids, therefore the system will utilize default nominal values instead of lot specific IMT fluid concentration values for calculation of the calibrations and results for the Na, K, and Cl methods.

Where Was This Sold?

The products were distributed to the following foreign countries: Argentina, Belgium, Brazil, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, and Vietnam. No affected products distributed in the United States.

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