Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk
Siemens is recalling RAPIDLab and RAPIDPoint blood gas analyzers because users can enter wrong patient IDs, risking 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 misidentification of samples could lead to incorrect patient care, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 140 units of RAPIDPoint 400 Series, RAPIDPoint 500, and RAPIDLab 1200 Series blood gas analyzers. The affected devices are intended for in vitro diagnostic use by healthcare professionals to test human whole blood. The recall covers all serial numbers and includes units distributed worldwide, including the United States and numerous international locations.
The recall is due to a software issue where users can inadvertently enter a wrong patient ID on the demographics screen. This error could lead to the misidentification of the blood sample, potentially resulting in incorrect diagnostic results for the patient.
Healthcare professionals using these devices should contact Siemens Healthcare Diagnostics Inc for further instructions on how to resolve the issue. Consumers are not directly affected as these are professional medical devices.
The recalled product
- Product
- Siemens RAPIDLab¿ 1260 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
- Affected units
- 140
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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