Siemens Atellica Lab Analyzers Risk Falsely Elevated Cholesterol Results
Siemens Atellica CH and CI analyzers may produce falsely elevated cholesterol and lipid test results (2–16% high) after iron tests. This affects clinical calibration, quality control checks, and patient 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 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: FDA Class II device with potential for false test results affecting clinical decision-making in cholesterol and lipid testing. No patient illnesses or injuries reported; the hazard is analytical error without documented harm.
Plain-English summary
Siemens Healthcare Diagnostics is recalling the Atellica CH Iron3 reagent due to a cuvette contamination issue affecting both Atellica CH and Atellica CI laboratory analyzers.
When an iron measurement is completed, residual reagent can contaminate the next test in the cuvette. This causes falsely elevated results for cholesterol (Chol_2), LDL cholesterol (LDLC), and triglycerides (Trig_2) measurements, with a positive bias ranging from 2 to 16%. The error affects laboratory calibration, quality control checks, and patient test results.
The recall involves 8,721 units distributed worldwide, including the United States, Argentina, Australia, Canada, and over 30 other countries. All lots of the Atellica CH Iron3 reagent are affected (UDI-DI: 00630414610849). Healthcare providers using these analyzers should review cholesterol and lipid results, particularly those following iron measurements, and contact Siemens Healthcare Diagnostics for corrective actions.
The recalled product
- Product
- Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica¿ CI Analyzer and Atellica¿ CH Analyzer Siemens Material Number (SMN): 11537211
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 8,721
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)
- UDI-DI: 00630414610849 All lots
Distribution
Distributed nationwide across the United States.
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