Atellica CH β2-Microglobulin Reagent Produces Falsely Depressed Results
Siemens Atellica CH β2-Microglobulin reagent may produce falsely depressed test results for samples between 18-30 mg/L, potentially leading to missed or delayed kidney disease diagnoses. No illnesses have been reported.
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 a Class II medical device recall affecting a diagnostic reagent that can produce falsely depressed results for certain sample concentrations. While no illnesses or injuries have been reported, the product represents a risk-of-harm situation where diagnostic errors could result in missed diagnoses of kidney disease.
Plain-English summary
Siemens Healthcare Diagnostics is recalling the Atellica CH β2-Microglobulin (B2M) reagent, an in vitro diagnostic used to measure β2-microglobulin levels in human blood serum and plasma. The recall affects approximately 11,330 units with worldwide distribution, including the United States and numerous other countries.
The reagent has a potential defect: when auto-diluting samples above a measuring interval of 18.00 mg/L up to 30.00 mg/L, test results can be falsely depressed—meaning artificially low. Accurate β2-microglobulin measurement is critical for diagnosing and monitoring kidney disease and certain immune disorders.
Healthcare providers should review patient test results from affected lots to identify potentially inaccurate measurements. Patients who received test results from affected reagent lots should consult their healthcare provider about potential retesting if clinically indicated. No illnesses or injuries have been reported to date.
The recalled product
- Product
- Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- 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-DI: 00630414595566 All in-date and future Atellica CH B2M reagent lots
Distribution
Distributed nationwide across the United States.
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