Siemens Recalls Dimension CREA Tests for Falsely Depressed Results
Siemens Healthcare Diagnostics is recalling Dimension CREA and Dimension Vista CREA tests because they may produce falsely depressed creatinine results in the presence of hemolysis.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic) where injury has not yet been reported, fitting the High severity criteria for potential clinical misdiagnosis without confirmed adverse events.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension CREA and Dimension Vista CREA in vitro diagnostic tests. These tests are intended for the quantitative determination of creatinine in human serum, plasma, and urine. The recall involves 238,634 units of Dimension CREA and 32,165 units of Dimension Vista CREA.
The recall was initiated because the tests may produce falsely depressed results. Specifically, for a creatinine concentration of 1.5 mg/dL, the Dimension CREA method may show results up to 12.7% lower, and the Dimension Vista CREA method may show results up to 22% lower, when hemolysis exceeds 200 mg/dL and 300 mg/dL, respectively.
The affected products were distributed worldwide, including nationwide in the United States and in numerous other countries. Healthcare facilities and laboratories should stop using the affected lot numbers and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Distribution
Distributed nationwide across the United States.
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