Siemens Recalls Atellica CH Creatine Kinase Reagent Due to Absorbance Trend
Siemens Healthcare Diagnostics is recalling 899 units of Atellica CH Creatine Kinase (CK_L) Reagent because a steady upward trend in blank absorbance was observed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential diagnostic error (absorbance trend) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 899 units of Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642. The affected units have serial numbers 280765, 280766, and 280767. The product is intended for in vitro diagnostic use to determine creatine kinase activity in human plasma or serum on ADVIA Chemistry XPT systems.
The recall was initiated because a steady upward trend in blank (u) absorbance was observed. This issue may affect the accuracy of the diagnostic results. The affected products were distributed worldwide.
Healthcare facilities and laboratories should stop using the affected reagent and contact Siemens Healthcare Diagnostics for further instructions. Consumers do not use this product directly, as it is a professional in vitro diagnostic reagent.
The recalled product
- 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…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 899
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Serial Numbers: 280765
- 280766
- 280767
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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