Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk
Siemens is recalling RAPIDLab 1265 blood gas analyzers because users may enter wrong patient IDs, leading to sample misidentification.
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) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 2,939 units of the RAPIDLab 1265 system blood gas analyzer. The recall covers units distributed worldwide, including the United States and numerous international locations.
The recall is due to a software issue where users of the RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzers can inadvertently enter a wrong patient ID on the demographics screen. This error could ultimately lead to the misidentification of the sample.
Healthcare professionals using these devices should contact Siemens Healthcare Diagnostics Inc for further instructions on how to address the issue.
The recalled product
- Product
- Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following pa
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 2,939
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 (1)
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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