medical Class II Updated 2019-07-10

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code

Recalled Product

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.


Hazard / Issue

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

Issued by

FDA

Distribution: Worldwide distribution.
Lot/Code Info: Serial Numbers: 465336,465663,468449
View official government recall

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