Class II — Potential Health Hazard

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

Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF Recalled by Siemens Healthcare Diagnostics, Inc. Due to Dimension Magnesium (MG) Flex reagent cartridge lots may...

Date: August 17, 2022
Company: Siemens Healthcare Diagnostics, Inc.
Status: Ongoing
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 Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57

Quantity: 26851 units

Why Was This Recalled?

Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in the absence of an Abnormal Reaction flag. Based on customer data, imprecision leading to erroneous, unflagged patient results with a bias of -15 to -59% may occur

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