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 Potential for calibration error resulting in QC failures...

Date: September 23, 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

Quantity: 1432

Why Was This Recalled?

Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.

Where Was This Sold?

This product was distributed to 35 states: AL, AZ, AR, CA, CO, DE, FL, GA, IL, IN, IA, KS, KY, LA, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, WA, WV, DC

Affected (35 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