Siemens Healthcare Diagnostics Inc recalls RAPIDPOINT 500e Blood Gas System
Recalled Product
RAPIDPOINT 500e Blood Gas System
Hazard / Issue
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.
Issued by
FDA
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