The Recall Desk
HighFDA (Devices)·Z-0987-2015·Announced 2015-01-21

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.

What this means for you

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 CentraLin
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:

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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