FDA (Devices) recall action 93240
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
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.
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.