Atellica CH protein test reagent may produce falsely low results
Siemens Healthcare's Atellica CH urinary and cerebrospinal fluid protein test (11,811 units) may produce falsely depressed results in patient samples and quality control materials. Affected laboratories should verify test results and contact the manufacturer.
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: FDA Class II medical device with potential for falsely depressed test results that could affect patient diagnosis and care. No illnesses or injuries reported. Meets the criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics is recalling 11,811 units of its Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) test worldwide, including across the US and more than 70 countries.
The test reagent has a potential for producing falsely depressed (abnormally low) results when measuring protein levels. This affects patient samples, quality control materials, and calibration procedures. Falsely low results could lead to inaccurate test reporting and delayed clinical decision-making.
The recall applies to all lot numbers of Material Number 11097543. The affected test code is UCFP with UDI-DI 00630414279206. Laboratories using this test should contact Siemens Healthcare Diagnostics for guidance on how to proceed with existing test results and future testing.
The recalled product
- Product
- Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- diagnostic-error
- false-negative-test
- calibration-error
Distribution
Distributed nationwide across the United States.
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