Siemens ADVIA Centaur XPT Software Recall for Workflow Issues
Siemens is recalling ADVIA Centaur XPT software versions V1.0.1 through V1.2 due to issues that may delay testing and affect system workflow.
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 2/5 (Moderate).
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 describes a potential delay to testing and workflow issues without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving operational issues without reported harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling software versions V1.0.1, V1.0.2, V1.0.3, V1.1, and V1.2 for the ADVIA Centaur XPT System. The ADVIA Centaur XPT System is a stand-alone, continuous operation immunochemistry analyzer used to perform various laboratory functions, including aspirating and dispensing samples, performing dilutions, and measuring photon emissions.
The recall is due to multiple software issues that may affect the operation and workflow of the system. These issues create a potential for an apparent delay to testing when they occur. The software issues may impact all analytes available on the ADVIA Centaur XPT System test menu.
The recall affects 17 units in the United States and 712 units in foreign countries. In the US, the units were distributed to New Hampshire, Maryland, Mississippi, Minnesota, Illinois, Texas, California, and Washington. The recall covers all serial numbers for the specified software versions.
The recalled product
- Product
- ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds…
- 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 (8)
- All Serial Numbers
- 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
- 11219656)
- V1.1 (Bundle 1.1.243 SMN 11221979
- 11222064) and V1.2 (Bundle: 1.2.223.0 SMN: 11222258
- 11223813).
Distribution
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