FDA Device recall Z-0422-2024
RAPIDPOINT 500e Blood Gas System
- FDA Device
- Class II
- ongoing
- Published 2023-12-06
On 2023-12-06 the FDA classified a Class II recall of RAPIDPOINT 500e Blood Gas System by Siemens Healthcare Diagnostics, citing there are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPI….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0422-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-26 |
| Published | 2023-12-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
RAPIDPOINT 500e Blood Gas System
Reason
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.
Identifiers
| code_info | Material No. 11416751, 11416752, 11416754, & 11416755; UDI-DI: 00630414286150, 00630414286167, 00630414286174, & 00630…Material No. 11416751, 11416752, 11416754, & 11416755; UDI-DI: 00630414286150, 00630414286167, 00630414286174, & 00630414286143; All Units and Software Versions. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0422-2024%22
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