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 Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic Recalled by Siemens Healthcare Diagnostics, Inc. Due to Complaints were received regarding variability in recovery of...

Date: December 5, 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

Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant patients.

Quantity: 1586

Why Was This Recalled?

Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.

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