Siemens ADVIA Chemistry XPT Recall for A1c Calculation Error
Siemens is recalling ADVIA Chemistry XPT systems due to a software error that causes falsely low Hemoglobin A1c results in IFCC units.
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: The recall involves a medical device that produces inaccurate diagnostic results (falsely depressed HbA1c), which poses a risk of harm to patients through potential misdiagnosis or treatment errors, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Chemistry XPT System, an automated clinical chemistry analyzer. The recall is due to an error in the ratio equation provided on the ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks (SMN: 11127343 and 11222123). This specific software issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when Hemoglobin A1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR).
The error in the ratio equation used to calculate these results causes falsely depressed HbA1cR values. This means the reported results may be lower than the actual patient values, which could impact clinical decision-making. The issue does not affect other tests or HbA1c results reported in non-IFCC units.
The recall affects 32 units in the United States and 197 units in foreign countries. Domestic distribution includes Massachusetts, New York, Michigan, Illinois, Texas, Colorado, Arizona, California, and Washington. Foreign distribution includes Australia, Austria, Bahrain, Brazil, China, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Singapore, Slovakia, Spain, Sweden, Turkey, United Kingdom, and Vietnam. Healthcare facilities should contact Siemens for instructions on how to correct the software and manage affected patient data.
The recalled product
- Product
- ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR). The ADVIA…
- 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)
- CA1275002940294 and lower
Distribution
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