Class III — Low Risk

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

Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an Recalled by Siemens Healthcare Diagnostics, Inc. Due to Cartridges are leaking. The leaking is observed when...

Date: August 3, 2012
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 Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Quantity: 583 cartons

Why Was This Recalled?

Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.

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