medical Class II Updated 2023-12-06

Siemens Healthcare Diagnostics Inc recalls RAPIDPOINT 500 Blood Gas System

Recalled Product

RAPIDPOINT 500 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

Distribution: Nationwide (United States)
Lot/Code Info: Material No. 10492730, 10696855, 10696857, & 10697306; UDI-DI:00630414589169, 00630414590851, 00630414590868, & 00630414590844; All Units and Software Versions.
View official government recall

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