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.
Reported: July 10, 2019 Initiated: May 3, 2019 #Z-1913-2019
Product Description
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.
Reason for Recall
A steady upward trend in blank (u) absorbance was observed
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 3,386
- Distribution
- Worldwide distribution.
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 3,386.
Why was this product recalled? ▼
A steady upward trend in blank (u) absorbance was observed
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2019. Severity: Moderate. Recall number: Z-1913-2019.
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