Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 110
Recalled Product
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.
Hazard / Issue
A steady upward trend in blank (u) absorbance was observed
Issued by
FDA
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