Siemens Atellica CH Analyzer: Reagent Carryover Affecting Magnesium Test Results
Siemens Healthcare Diagnostics has recalled the Atellica CH LDL Cholesterol Direct diagnostic device due to reagent carryover affecting magnesium test accuracy. Approximately 8420 units distributed nationwide and internationally are affected.
What this means for you
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: This is an FDA Class II recall for a diagnostic device with potential for patient harm through inaccurate test results. No reported illnesses or injuries are documented in the source material, which per the rubric limits the score to a maximum of 3. The risk of inaccurate magnesium measurements affecting patient diagnosis and clinical decisions classifies this as a risk-of-harm product, warranting 'High' severity.
Plain-English summary
The Atellica CH LDL Cholesterol Direct (DLDL) is an in vitro diagnostic device manufactured by Siemens Healthcare Diagnostics. It quantitatively measures LDL cholesterol levels in human serum and plasma samples. Approximately 8420 units have been affected by this recall.
The recall is due to a reagent carryover issue. When the Atellica CH Analyzer runs multiple assays in sequence—including tests for LDL Cholesterol Direct, Total Protein II, Triglycerides, and Triglycerides_2—residual reagent can persist and affect the accuracy of subsequent magnesium (Mg) measurements on the same device. This contamination can result in inaccurate magnesium test results.
The recalled devices are identified by UDI 00630414596181 and all lot numbers are affected. Distribution has been nationwide and internationally across multiple countries. Healthcare facilities using this device should verify their equipment matches this identification to determine if they have affected units.
The recalled product
- Product
- Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- reagent-carryover
- inaccurate-test-results
- diagnostic-error
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: 00630414596181 All Lots
Distribution
Distributed nationwide across the United States.
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