Recall Z-0422-2024 ยท JGS Electrode, Ion Specific, Sodium
Siemens Healthcare Diagnostics Inc
RAPIDPOINT 500e Blood Gas System
| Date | Dec 1, 2023 (initiated Sep 26, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | The firm issued an Urgent Medical Device Correction notice on 9/26/2023 to customers asking that customers review the notice with the facility's Medical Director to determine the appropriate course of action for previously generated results, complete and return the Field Correction Effectiveness Check Form within 30 days, forward this notice to customers if your firm is a distributor, and retain the notification in your system's Operator's Guide and forward to those who may have received product. The Field Correction Effectiveness Check Form is to be returned via email to uscctsfcaecfax.team@s |
| Quantity | 8,749 units |
| Distribution | Domestic: Nationwide Distribution. Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Con |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192240 | RAPIDPoint 500e Blood Gas System Siemens Healthcare Diagnostics, Inc., Mar 27, 2020 |