Device 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.
Z-1914-2019
Product summary
- Event
- Event 82980
- Status
- Terminated
- Classification
- Class II
- Quantity
- 899
- Official record key
device-enforcement:Z-1914-2019
Official wording
Reason: A steady upward trend in blank (u) absorbance was observed
Code information: Serial Numbers: 280765, 280766, 280767
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
A steady upward trend in blank (u) absorbance was observed