Siemens CentraLink Data Management System Software Recall
Siemens recalls CentraLink software because the sample query function may fail to return all samples from Dimension Vista systems under specific configurations.
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. The hazard involves a software defect that may result in incomplete data retrieval, which is a functional issue rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the CentraLink Data Management System software. This software serves as a network solution provider and multi-system data manager for laboratory instruments and automation systems, consolidating data so operators can review and edit patient and quality control results from a single location.
The recall is due to a defect in the sample query function. When 'Instrument' or 'Instrument Group' is used as a search criterion, the function may not return all samples from Dimension Vista systems if onboard aliquot support rules are configured in the CentraLink system. This issue affects 1,941 units of the software, specifically versions 14.0.5 and 14.0.8, which were distributed worldwide and in the United States.
Healthcare facilities using the affected software should contact Siemens Healthcare Diagnostics for further instructions on how to resolve the data retrieval issue.
The recalled product
- Product
- CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,941
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 (18)
- Product: Siemens CentraLink Data Management System
- v14.0.5 Material Number (SMN)10811741
- 10811742
- 10811743
- 10814298
- 10814877
- 10814880
- 10814881
- Product: CentraLink Data Management System
- v14.0.8 Material Number (SMN)10815474
- 10816519
- 10816520
- 10816521
- 10816522
- 10816523
- 10816524
- 10817180
- 10817181
Distribution
Distributed nationwide across the United States.
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