Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1253-2015·Announced 2015-03-18

Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Neonatal Bilirubin Variability

Siemens is recalling 4,376 RAPIDPoint 500 Blood Gas Analyzers worldwide because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves increased variability in a specific test parameter under extreme conditions, which is a moderate risk to diagnostic accuracy but does not involve direct physical injury or reported illnesses.

Plain-English summary

Siemens Healthcare Diagnostics Inc is recalling 4,376 RAPIDPoint 500 Blood Gas Analyzers. The devices are distributed worldwide, including the United States, Canada, Mexico, and numerous international locations. The recall covers all serial numbers for the affected material numbers.

The recall is due to a potential issue with the neonatal bilirubin (nBili) parameter. The nBili parameter may exhibit increased variability when the nBili concentration is greater than 12 mg/dl and the total hemoglobin (tHb) concentration exceeds the upper reportable range of greater than 25 g/dl. This variability could affect the precision of the test results under these specific conditions.

The RAPIDPoint 500 system is designed for professional use in point-of-care or laboratory environments to test blood gases, electrolytes, metabolites, and hemoglobin derivatives. Users should contact Siemens Healthcare Diagnostics Inc for instructions on how to address the issue with their devices.

The recalled product

Product: RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, 10697306. 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…
Manufacturer: Siemens Healthcare Diagnostics Inc
Category: Medical Device — Laboratory Equipment
Hazard: inaccurate-reading
Affected units: 4,376

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.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics Inc

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Same hazard · inaccurate reading