Class II — Potential Health Hazard

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

Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient Recalled by CSL Behring GmbH Due to Negative bias for the carbohydrate-deficient transferrin (CDT) measurement...

Date: March 2, 2020
Company: CSL Behring GmbH
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 CSL Behring GmbH directly.

Affected Products

Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997

Quantity: 297 PCK US; 1247 PCK OUS

Why Was This Recalled?

Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring

Where Was This Sold?

This product was distributed to 5 states: IN, KS, MO, OH, VA

Affected (5 states)Not affected

About CSL Behring GmbH

CSL Behring GmbH has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report