Siemens Dimension Vista Lab Systems Recalled for Potential ECREA Test Inaccuracy
Siemens is recalling Dimension Vista 500 and 1500 lab systems because ECREA test results may be falsely elevated in isolated cases.
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 potential test inaccuracy (false elevation) rather than a direct physical injury or contamination, and the source describes the risk as 'remote' and occurring in 'isolated cases,' fitting the criteria for a moderate severity recall involving a diagnostic device.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Vista 500 and Dimension Vista 1500 Intelligent Lab Systems. These are in vitro diagnostic devices used in clinical settings to measure various analytes in human body fluids.
The recall is due to a potential for ECREA (effective creatinine clearance) test results to be falsely elevated by more than 15 percent. This issue occurs in isolated cases when the ECREA test is processed immediately after the weekly automated Acid Clean routine during the Probe Test.
The recall affects 2,733 systems distributed worldwide, including the United States, Puerto Rico, Canada, and numerous countries in Europe, Asia, and the Middle East. Siemens is the recalling firm. Users should contact Siemens Healthcare Diagnostics for instructions on how to address this issue.
The recalled product
- Product
- Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 2,733
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 (1)
- Device Listing D011374 Serial Number: All serial numbers
Distribution
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