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¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: Recalled by Siemens Healthcare Diagnostics, Inc. Due to Negative Bias with Lot EA9227.

Date: July 15, 2019
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¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia.

Quantity: 815 kits

Why Was This Recalled?

Negative Bias with Lot EA9227.

Where Was This Sold?

This product was distributed to 34 states: AK, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, OK, OR, SD, TN, TX, VT, VA, WA, WI

Affected (34 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