Class II — Potential Health Hazard

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

Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated Recalled by Siemens Healthcare Diagnostics, Inc. Due to An overflow flag //// is displayed in the...

Date: December 17, 2013
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

Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.

Quantity: 1563

Why Was This Recalled?

An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result.

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