Siemens ADVIA Centaur XPT Software Recalled for Potential Result Errors
Siemens Healthcare Diagnostics is recalling ADVIA Centaur XPT system software versions V1.0.1 through V1.1 due to eight identified issues that may affect test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, indicating a theoretical risk of incorrect results rather than a direct health hazard.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific versions of the ADVIA Centaur XPT system software, including V1.0.1, V1.0.2, V1.0.3, and V1.1. The recall involves 446 units distributed worldwide, with 3 units in the United States and 443 units internationally. The system is intended for professional use in a laboratory environment for in vitro diagnostic testing.
The recall was initiated because eight issues were identified that may affect the results generated by the system software. The source text does not specify the nature of these issues or report any illnesses or injuries associated with the software. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test but should only be made by a physician after all clinical and laboratory findings have been evaluated.
Laboratories using the affected software versions should contact Siemens Healthcare Diagnostics for further instructions on how to address the identified issues.
The recalled product
- Product
- ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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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