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Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The A
Recalled July 10, 2019 · FDA recall Z-1913-2019 · Siemens Healthcare Diagnostics
Hazard
A steady upward trend in blank (u) absorbance was observed · FDA Class II
Units
3,386
Sold at
Worldwide distribution.
Description
A steady upward trend in blank (u) absorbance was observed
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.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →