Siemens Atellica CH β2-Microglobulin Assay Lot 211446 Recalled for Measurement Bias
Siemens Healthcare Diagnostics recalled lot 211446 of the Atellica CH β2-Microglobulin assay due to analytical bias in test results. The assay showed positive bias up to 20.9% at some concentrations and negative bias up to 10.5% at others.
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 medical device recall with significant analytical bias (positive bias up to 20.9%, negative bias up to 10.5%) in diagnostic test results. No hospitalization or injury reports present. This constitutes a risk-of-harm scenario where diagnostic inaccuracy could lead to improper clinical decision-making.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. has recalled lot 211446 of the Atellica CH β2-Microglobulin (B2M) assay, an in vitro diagnostic test used to measure β2-microglobulin levels in human serum and plasma. The test is used in clinical laboratories to assess kidney function and monitor certain medical conditions.
The recall was initiated due to analytical bias in the assay results. Specifically, the test showed a positive bias of up to 20.9% at β2-microglobulin concentrations around 1.5 mg/L, and a negative bias of up to 10.5% at concentrations around 15 mg/L. This means patient results from the affected lot may be inaccurate.
Approximately 46 units of the recalled assay were distributed in the United States, primarily to states including California, Colorado, Massachusetts, Maryland, Mississippi, North Carolina, Nebraska, New Hampshire, Ohio, Virginia, and Wisconsin. An additional 794 units were distributed internationally to numerous countries worldwide. Healthcare facilities that received the affected lot (lot number 211446, UDI: 00630414595566) should contact Siemens Healthcare Diagnostics for guidance on appropriate actions, which may include test result verification or reanalysis of patient samples.
The recalled product
- Product
- Atellica CH ¿2-Microglobulin (B2M) -M) Assay for 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.
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)
- Lot Number: 211446 UDI: 00630414595566
Distribution
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