RAPIDPOINT 500e Blood Gas System Recalled Due to Drug Interference
Siemens RAPIDPOINT 500e blood gas systems may show falsely elevated sodium readings in patients taking Perhexiline Maleate or Atomoxetine, risking misdiagnosis and inappropriate treatment of electrolyte imbalances.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a diagnostic instrument where measurement errors can lead to patient misdiagnosis and inappropriate treatment. No hospitalizations or serious injuries are explicitly reported in the source, but the potential for iatrogenic harm from erroneous clinical decisions constitutes a risk-of-harm product meeting the rubric criterion for High severity.
Plain-English summary
Siemens Healthcare Diagnostics has recalled the RAPIDPOINT 500e and RAPIDPOINT 500 Blood Gas Systems due to potential drug interference. When patients are taking Perhexiline Maleate or Atomoxetine Hydrochloride, these analyzers may produce falsely elevated sodium measurements. Approximately 8,749 units are affected, distributed nationwide in the U.S. and internationally.
The erroneous sodium readings can lead to serious diagnostic errors and inappropriate patient treatment. Falsely elevated results may cause clinicians to overlook genuine hyponatremia in affected patients, delaying recognition and treatment. Alternatively, false readings may prompt clinicians to treat suspected hypernatremia, which can inadvertently cause iatrogenic hyponatremia through inappropriate therapy. These measurement errors have resulted in delays in accurate patient diagnosis and optimal clinical management.
Affected units include those with material numbers 11416751, 11416752, 11416754, and 11416755. All software versions of these analyzers are affected.
The recalled product
- Product
- RAPIDPOINT 500e Blood Gas System
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 8,749
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 (9)
- Material No. 11416751
- 11416752
- 11416754
- & 11416755
- UDI-DI: 00630414286150
- 00630414286167
- 00630414286174
- & 00630414286143
- All Units and Software Versions.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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