Siemens Blood Gas Analyzers Recalled for Patient Identification Error Risk
Siemens is recalling RAPIDPoint and RAPIDLab blood gas analyzers because users may enter wrong patient IDs, leading to sample misidentification.
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 is classified as FDA Class II. The hazard involves the risk of sample misidentification, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling the RAPIDPoint 400 Series, RAPIDPoint 500, and RAPIDLab 1200 Series blood gas analyzers. The recall involves 2,152 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 ultimately lead to the misidentification of blood samples. The affected units include all serial numbers.
Healthcare professionals using these devices should contact Siemens Healthcare Diagnostics Inc for instructions on how to resolve the issue. The source text does not specify a particular action for consumers, as these are professional medical devices.
The recalled product
- Product
- Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and…
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 2,152
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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