Agency classClass IIOur severity:High FDA (Devices)·Z-0102-2014·Announced 2013-11-06

Siemens RAPIDPoint 400 Blood Gas Analyzer Recalled for Sample Misidentification Risk

Siemens Healthcare Diagnostics Inc. is recalling RAPIDPoint 400 series blood gas analyzers because users may enter incorrect 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 and 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 828 units of the RAPIDPoint 400 series blood gas analyzer. The recall covers the RAPIDPoint 400, RAPIDPoint 500, and RAPIDLab 1200 series devices, which are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, and hemoglobin derivatives in whole blood samples.

The recall was initiated because users can inadvertently enter a wrong patient ID on the demographics screen. This error could ultimately lead to the misidentification of the sample. The agency has classified this as a Class II recall.

The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries. All serial numbers are included in this recall. Users of these systems should contact Siemens Healthcare Diagnostics Inc. for further instructions on how to address the issue.

The recalled product

Product: Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.…
Manufacturer: Siemens Healthcare Diagnostics Inc
Category: Medical Device — Laboratory Equipment
Hazard: mis-labeling
sample-misidentification
Affected units: 828

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.

See all 7 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics Inc

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