Class III — Low Risk

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

Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC Recalled by Siemens Healthcare Diagnostics, Inc. Due to Siemens has received complaints of customers experiencing slopes...

Date: July 17, 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

Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.

Quantity: 1,894 cartons

Why Was This Recalled?

Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay from being run on the Dimension Vista(R) System.

Where Was This Sold?

This product was distributed to 39 states: AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, DC

Affected (39 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