Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk
Siemens is recalling RAPIDLab 1245 blood gas analyzers because users may enter wrong patient IDs, potentially 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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential misidentification of samples.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 274 units of the RAPIDLab 1245 system blood gas analyzer. The recall covers units distributed worldwide, including the United States and numerous international markets.
The recall was initiated because 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. The RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood.
Healthcare professionals should contact Siemens Healthcare Diagnostics Inc for further instructions on how to address this issue. The recall number is Z-0106-2014.
The recalled product
- Product
- Siemens RAPIDLab¿ 1245 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…
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 274
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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