Class II — Potential Health Hazard

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

ADVIA Chemistry Creatine Kinase (CK_L) reagent Recalled by Siemens Healthcare Diagnostics, Inc. Due to A steady upward trend in blank (u) absorbance...

Date: May 3, 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

ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.

Quantity: 3,386

Why Was This Recalled?

A steady upward trend in blank (u) absorbance was observed

Where Was This Sold?

Worldwide distribution.

About Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.

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