Class III — Low Risk

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

Dimension IRON Flex reagent cartridges Recalled by Siemens Healthcare Diagnostics, Inc. Due to Siemens Healthcare Diagnostics has become aware of deferoxamine...

Date: August 25, 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

Dimension IRON Flex reagent cartridges

Quantity: 38,230 cartridges

Why Was This Recalled?

Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU).

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