Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Neonatal Bilirubin Variability
Siemens is recalling 3,420 RAPIDPoint 405 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, and the source text describes a potential for increased variability in test results without reporting any specific injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving potential performance issues without confirmed harm.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 3,420 units of the RAPIDPoint 405 Blood Gas Analyzer. The recall covers devices distributed worldwide, including the United States, Canada, Mexico, and numerous countries in Europe, Asia, Africa, and South America. The affected devices are identified by specific Siemens material numbers and include all serial numbers.
The recall is issued because the neonatal bilirubin (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. These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in whole blood samples.
Healthcare facilities and laboratories should contact Siemens Healthcare Diagnostics Inc for instructions on how to manage the affected devices. No specific consumer action is required for the general public, as these are professional medical devices.
The recalled product
- Product
- RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total…
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 3,420
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
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.
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