Z-1914-2019 Class II Terminated
FDA device recall Z-1914-2019 was initiated by Siemens Healthcare Diagnostics, Inc. on May 3, 2019 and is designated Class II. Reason for recall: A steady upward trend in blank (u) absorbance was observed The recall status is terminated (terminated January 19, 2021). Affected quantity: 899.
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2019
- Initiation Date
- May 3, 2019
- Termination Date
- January 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 899
Product Description
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.
Reason for Recall
A steady upward trend in blank (u) absorbance was observed
Distribution Pattern
Worldwide distribution.
Code Information
Serial Numbers: 280765, 280766, 280767