Recall Z-0423-2024— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-0423-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-26

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2023-09-26. It names one FDA 510(k) clearance: K113216. Product: RAPIDPOINT 500 Blood Gas System. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-09-26
Firm location: Norwood, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K113216 — RAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare Diagnostics·cleared 2012-05-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

RAPIDPOINT 500 Blood Gas System

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.