Atellica CH Creatine Kinase — Class II medical device recall Z-1914-2019
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2019-07-10. A steady upward trend in blank (u) absorbance was observed
| Recall number | Z-1914-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2019-05-03 |
| Classified | 2019-07-02 |
| Reported by FDA | 2019-07-10 |
| Terminated | 2021-01-19 |
| Quantity | 899 |
| UPC / GTIN / UDI-DI | 00630414006642 |
| Serial numbers | 280765, 280766, 280767 |
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.
Reason for recall
A steady upward trend in blank (u) absorbance was observed
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.