Siemens ADVIA Chemistry Creatine Kinase Reagent Recalled for Absorbance Trend
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Creatine Kinase (CK_L) reagent due to a steady upward trend in blank absorbance.
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780. The recall involves 3,386 units with serial numbers 465336, 465663, and 468449. The product was distributed worldwide.
The recall was initiated because a steady upward trend in blank (u) absorbance was observed. This reagent is used for in vitro diagnostic purposes to determine creatine kinase activity in human plasma or serum on ADVIA Chemistry XPT systems.
Healthcare facilities and laboratories should stop using the affected reagent and contact Siemens Healthcare Diagnostics for instructions on return or replacement. No specific illnesses or injuries have been reported in the source text.
The recalled product
- 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…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 3,386
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: 465336
- 465663
- 468449
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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