Siemens Healthcare Diagnostics Inc RapidPoint 405 System Analyzers The RP405 is capable of testing all of the analytes listed below including Co-Oximetry. The Siemens 400 series system is intended for point of care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RapidPoint 405 System Analyzers The RP405 is capable of testing all of the analytes listed below including Co-Oximetry. The Siemens 400 series system is intended for point of care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples.
Brand
Siemens Healthcare Diagnostics Inc
Lot Codes / Batch Numbers
Software Versions prior to 3.5.1
Products Sold
Software Versions prior to 3.5.1
Siemens Healthcare Diagnostics Inc is recalling RapidPoint 405 System Analyzers The RP405 is capable of testing all of the analytes listed below in due to Software: Reference sensor failure may result in inaccurate pH reuslts. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software: Reference sensor failure may result in inaccurate pH reuslts
Recommended Action
Per FDA guidance
An "Urgent Field Safety Notice" dated September 2009 was sent via overnight mail to customers and included software Version 3.5.2 with instructions for install that will detect and prevent the reporting of potentially errant test results. The customers are requested to please install the included software update immediately and return the attached Fax back form. Siemens will provide the mandatory update to all customers with the Rapidpoint 400 /405 test system. If you have any questions, please contact your local Technical Support at 508-359-3877.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026