Siemens CentraLink Software Recalled for Potential Erroneous Patient Results
Siemens Healthcare Diagnostics is recalling CentraLink Data Management System software versions 16.0.2 and 16.0.3 due to a defect that may cause erroneous patient results.
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 risk-of-harm product (medical device software) where injury has not yet been reported, but the potential for erroneous patient results poses a significant risk to patient safety.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 186 units of CentraLink Data Management System software, specifically versions 16.0.2 and 16.0.3. These clinical laboratory information modules are used to consolidate test orders and results, manage quality control, and provide routing information to automation systems.
The recall was initiated because an unexpected interface driver behavior was identified. This defect may cause quality control (QC) results to be assigned to an incorrect control lot number. If a QC test fails but appears to be passing due to this error, and the issue is not detected during QC review, it could lead to the reporting of erroneous patient results.
The affected software was distributed worldwide, including in the United States and numerous international locations such as Argentina, Australia, Germany, and the United Kingdom. Siemens Healthcare Diagnostics is the recalling firm. Users of this software should contact Siemens Healthcare Diagnostics for further instructions on how to address the issue.
The recalled product
- Product
- (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which consolida
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 186
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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