Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1914-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - 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.

Product Classification:

Class II

Date Initiated: May 3, 2019

Date Posted: July 10, 2019

Recall Number: Z-1914-2019

Event ID: 82980

Reason for Recall:

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

Status: Terminated

Product Quantity: 899

Code Information:

Serial Numbers: 280765, 280766, 280767

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated