Siemens ADVIA Chemistry Urea Nitrogen Reagent Recalled for Calibration Failures
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Urea Nitrogen Reagent due to increased calibration failures that prevent the system from generating results.
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. The hazard is a functional failure (calibration failure) that prevents result generation, rather than a direct physical injury or contamination risk, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) used on ADVIA 1800, 2400, and XPT Chemistry Systems. The recall is due to an increased incidence of calibration failures. When calibration fails, the system cannot generate results.
The affected product is identified by Lot # 408143 with an expiry date of 2018-06-28 and UDI# 00630414517513. The product was distributed nationwide and worldwide.
Users of these systems should stop using the affected reagent and contact Siemens Healthcare Diagnostics for further instructions or a replacement.
The recalled product
- Product
- ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Distribution
Distributed nationwide across the United States.
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