Siemens ADVIA Centaur XPT Immunoassay System Recall for Maintenance Setting Error
Siemens is recalling 292 ADVIA Centaur XPT Immunoassay Systems because the default daily maintenance setting may be incorrect, potentially affecting assay results.
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 is classified as FDA Class II, and the hazard involves potential impact on assay results (risk of harm) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 292 units of the ADVIA Centaur XPT Immunoassay System. The recall is due to a potential software configuration error where the default setting for the Daily Maintenance Task frequency may be set to "As needed" instead of "Daily." This issue affects systems running in English; systems running in other languages are not impacted.
The failure to perform daily maintenance may impact any assay performed on the affected systems. The issue can be detected through the monitoring of quality control and calibration results. The recall covers 3 units distributed domestically in the United States (Maryland, Minnesota, and Mississippi) and 289 units distributed internationally across 31 countries.
Healthcare facilities using the affected systems should contact Siemens Healthcare Diagnostics, Inc. for instructions on correcting the maintenance setting and verifying system performance. No specific lot numbers or serial codes were provided in the source text.
The recalled product
- Product
- ADVIA Centaur XPT Immunoassay System
- 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)
- None
Distribution
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