Siemens ADVIA Chemistry XPT Software Recall for Result Overwrite Risk
Siemens is recalling 7 ADVIA Chemistry XPT systems in Washington due to a software defect that may cause critical results to be overwritten.
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 with a risk of harm (erroneous critical results) where no specific injuries or illnesses have been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling seven ADVIA Chemistry XPT systems that are interfaced to the CentraLink Data Management System V14x. The recall is limited to units distributed in the state of Washington. The affected systems use specific catalog numbers 10817209 and 10818262.
The recall is due to a software defect in the CentraLink system. When the feature for sending preliminary or initial results is enabled, there is a risk that a critical result could be overwritten by the same result rather than displaying the repeated result. This error could cause an erroneous and critical result to appear as if it has been verified upon repeat.
Healthcare facilities using these specific configurations should contact Siemens Healthcare Diagnostics for further instructions on how to resolve the software issue.
The recalled product
- Product
- ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 7
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 (2)
- CentraLink" Data Management System V14x Catalog Numbers: 10817209
- 10818262
Distribution
Distributed in 1 state:
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