Siemens Healthcare Diagnostics, Inc. 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

Siemens Healthineers issued Urgent Medical Device Recall notices to domestic customers and Urgent Field Safety Notices to international customers dated May 8, 2019. Actions to be Taken by the Customer 1) Discontinue use of and discard the kit lots listed on the notice. 2) Review your inventory of these products to determine your laboratorys replacement needs and provide information to Siemens for reporting to the authorities. 3) Complete and return the Field Correction Effectiveness Check letter within 30 days. 4) Please review the letter with your Medical Director. 5) If you have received any complaints of illness or adverse events associated with the products listed in the notice, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. 6) Please retain the letter with your laboratory records and forward the letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.