Official recall record
RAPIDPOINT 500 Blood Gas System
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-09-26
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Siemens Healthcare Diagnostics Inc
What the authority reported
There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels with positive bias may lead to unrecognized hyponatremia and/or the inappropriate treatment of hypernatremia may lead to iatrogenic hyponatremia, resulted in a delay in patient diagnosis and optimal patient management.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2025-07-07 · US FDA — Medical Devices
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. - 2025-06-26 · US FDA — Medical Devices
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. - 2024-09-24 · US FDA — Medical Devices
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
All 38 official recall notices naming Siemens Healthcare Diagnostics, Inc. on this site →