Use cautionMedical device recall · FDA · Published October 26, 2023
Siemens Healthcare RAPIDPoint 500 Cartridges May Cause Delayed Diagnosis of Sodium
Siemens Healthcare recalls RAPIDPoint 500 Systems Measurement Cartridges with lactate that may cause delayed diagnosis of hypernatremia or hyponatremia, leading to serious health risks. Affected units have specific serial numbers.
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.
Take action
Contact the company
📍Recalling firmSiemens Healthcare Diagnostics Inc2 Edgewater Dr · Norwood, MA 02062-4637
“Siemens Healthcare RAPIDPoint 500 Cartridges May Cause Delayed Diagnosis of Sodium.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56997-siemens-healthcare-rapidpoint-500-cartridges-may-cause-delayed-diagnosis-of. Based on FDA recall #Z-0607-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0607-2024%22&limit=1).
The FDA announced on 2023-10-26 that Siemens Healthcare Diagnostics Inc. is recalling RAPIDPoint 500 Systems Measurement Cartridges (with Lactate) due to potential sensor errors. The hazard involves negative bias in sodium readings that could lead to serious injury from delayed diagnosis or unnecessary treatment.
How to tell if you have it
Brand: Siemens Healthcare
Product: RAPIDPoint 500 Systems Measurement Cartridge (with Lactate)
SMN: 10491447
UDI-DI: 00630414589756
Quantity: 6035 cartridges
The hazard
The cartridges have 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. This may also cause iatrogenic hypernatremia, especially if the true sodium result is near severe alteration thresholds. Additionally, the defect may cause a Question Result -----? error flag for multiple electrolytes on patient samples and quality control.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls since 2017-06-07. Recent similar recalls include the Siemens Atellica CH RCRP Test recall on 2026-08-17 and the Siemens Atellica CH Urine Albumin Recall on 2026-07-06. Other recent recalls of similar products include the Spectra Medical Devices Sodium Chloride Injection Recall (2026-07-06), the Medtronic Paradigm Insulin Pumps Recall (2026-02-13), and the Medline Namic Preceptor Manifold Recall (2026-03-24).
How to tell if you have this one
Check for the RAPIDPoint 500 Systems Measurement Cartridges with lactate. Affected units have serial numbers starting with 10491447 or 00630414589756.
Brand
Siemens Healthcare
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Nationwide with Worldwide Distribution to: 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 Congo, Republic Costa Rica C¿te dIvoire Croatia Cura¿ao Czech Republic Denmark Ecuador Egypt Estonia Fiji Finland France French Polynesia Georgia Germany Ghana Greece Guadeloupe Honduras Hong Kong Hungary Iceland India Indonesia Iran, Islamic Republic of Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Kosovo Kuwait Latvia Lebanon Lesotho Lithuania Luxembourg Macedonia, former Yugoslav Rep. of Malaysia Maldives Mali Martinique Mexico Moldova, Rep. of Montenegro Namibia Nepal Netherlands New Caledonia New Zealand Norway Oman Pakistan Palestinian Territory, Occupied Paraguay Peru Philippines Poland Portugal Qatar Republic Korea Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan, Province of China Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Great Britain United Republic of Tanzania Uruguay Uzbekistan Vietnam
Recall number
Product, codes & lots
Quantity
Z-0606-2024
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813; UDI-DI: 00630414947556 All serial numbers
0 cartridges US
Z-0607-2024
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491447; UDI-DI: 00630414589756 All serial numbers
6035 cartridges US
Z-0608-2024
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448; UDI-DI: 00630414589763 All serial numbers
6611 cartridges US
Z-0609-2024
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491449; UDI-DI: 00630414589770 All serial numbers
3505 Cartridges US
Based on the official FDA remedy
What to do — step by step
Check Cartridge Serial Numbers
Look for serial numbers starting with 10491447 or 00630414589756 on the cartridge.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide with Worldwide Distribution to: Albania Algeria Angola Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Botswana Brazil Brunei Darussalam Bulgaria Burkina Faso…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0607-2024 (October 26, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0607-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.