Siemens ADVIA Chemistry Systems Recalled for Potential Result Misinterpretation
Siemens is recalling ADVIA 1200 and 1650 chemistry systems because an overflow flag may cause users to misinterpret or edit test 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, but the hazard is a potential for user error (misinterpretation) rather than a direct physical injury or high-risk pathogen, fitting the Moderate criteria for low-risk issues without reported harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,563 units of the ADVIA 1200 and ADVIA 1650 Chemistry Systems. These are automated clinical chemistry analyzers used to run tests on human serum, plasma, or urine. The affected units were distributed worldwide, including nationwide in the USA and in Canada.
The recall is due to a software issue where an overflow flag is displayed in the result column when the algorithm cannot calculate a result or when the concentration is outside absorbance limits. This display allows users to potentially misinterpret or edit the result.
The recall affects specific software versions: ADVIA 1200 with V2.00 and V2.01, and ADVIA 1650 with V3.52 and V4.01. Users should contact Siemens Healthcare Diagnostics for instructions on how to address this issue.
The recalled product
- Product
- Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 1,563
Distribution
Distributed nationwide across the United States.
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