RAPIDPOINT 500 Blood Gas System: Drug Interference May Cause False Sodium Readings
Siemens RAPIDPOINT 500 Blood Gas System may produce falsely elevated sodium results due to drug interference from Perhexiline Maleate or Atomoxetine Hydrochloride. This could lead to missed hyponatremia or inappropriate treatment of hypernatremia.
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 3/5 (High).
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: FDA Class II medical device with no reported illnesses or deaths. The recall involves potential for measurement error leading to misdiagnosis and inappropriate treatment, representing risk of serious patient harm. Per the rubric, risk-of-harm products without reported injury score as High.
Plain-English summary
The RAPIDPOINT 500 Blood Gas System, manufactured by Siemens Healthcare Diagnostics Inc, is being recalled due to potential drug interferences. The system may produce falsely elevated sodium measurements when patients are taking Perhexiline Maleate or Atomoxetine Hydrochloride.
Falsely elevated sodium results can prevent recognition of hyponatremia (low blood sodium) or lead to inappropriate treatment of hypernatremia (high blood sodium). These measurement errors may result in delayed diagnosis and suboptimal patient management.
The recall involves 12,363 units distributed nationwide in the United States and internationally. All units and software versions of the RAPIDPOINT 500 system are affected.
The recalled product
- Product
- RAPIDPOINT 500 Blood Gas System
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 12,363
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. 10492730
- 10696855
- 10696857
- & 10697306
- UDI-DI:00630414589169
- 00630414590851
- 00630414590868
- & 00630414590844
- 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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