Official recall record
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determin
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-10-26
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00630414589763
- Brand on record
- Siemens Healthcare Diagnostics Inc
What the authority reported
RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary intervention for hyponatremia and result in iatrogenic hypernatremia especially if the true sodium result is near the thresholds of severe alterations, as well as cause a Question Result -----? error flag for multiple electrolytes on patient samples and quality control that may cause a delay of diagnosis or treatment.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2025-07-07 · US FDA — Medical Devices
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. - 2025-06-26 · US FDA — Medical Devices
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. - 2024-09-24 · US FDA — Medical Devices
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
All 38 official recall notices naming Siemens Healthcare Diagnostics, Inc. on this site →