Lower riskMedical device recall · FDA · Published September 26, 2023
Siemens RAPIDPOINT 500 Blood Gas System: Drug Interference Risk
Siemens recalls RAPIDPOINT 500 Blood Gas Systems that may show falsely high sodium levels when used with certain drugs, risking incorrect patient treatment.
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.
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Contact the company
📍Recalling firmSiemens Healthcare Diagnostics Inc2 Edgewater Dr · Norwood, MA 02062-4637
“Siemens RAPIDPOINT 500 Blood Gas System: Drug Interference Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57232-siemens-rapidpoint-500-blood-gas-system-drug-interference-risk. Based on FDA recall #Z-0423-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0423-2024%22&limit=1).
The FDA announced on September 26, 2023, that Siemens Healthcare Diagnostics Inc. is recalling its RAPIDPOINT 500 Blood Gas Systems due to potential drug interferences causing falsely elevated sodium results. The agency classified the recall as Class II and ongoing.
How to tell if you have it
Brand: Siemens Healthcare
Product: RAPIDPOINT 500 Blood Gas System
Material Numbers: 10492730, 10696855, 10696857, 10697306
According to the FDA, potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride may cause falsely elevated sodium results 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.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Siemens Atellica CH RCRP Test May Give False High Results (August 17, 2026), Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026), and Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Other recent recalls of similar products include Medline Namic Preceptor Manifold Recall (March 24, 2026), Spectra Medical Devices Sodium Chloride Injection Recall (July 6, 2026), and Abbott i-STAT EG6+ Cartridges May Show Wrong Blood Gas Results (April 1, 2026).
How to tell if you have this one
Check for the model numbers 10492730, 10696855, 10696857, or 10697306 on the device. All units and software versions are affected.
Brand
Siemens Healthcare
Category
Medical device
FDA recall event · 2 products
All 2 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
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, Congo, Republic, Costa Rica, Cote dIvoire, Croatia, Curacao, Cyprus, 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, Malaysia, Maldives, Mali, Martinique, Mexico, Moldova, Montenegro, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestinian Territory, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom Great Britain, Uruguay, & Vietnam.
Recall number
Product, codes & lots
Quantity
Z-0422-2024
RAPIDPOINT 500e Blood Gas System; Material No. 11416751, 11416752, 11416754, & 11416755; UDI-DI: 00630414286150, 00630414286167, 00630414286174, & 00630414286143; All Units and Software Versions.
8,749 units
Z-0423-2024
RAPIDPOINT 500 Blood Gas System; Material No. 10492730, 10696855, 10696857, & 10697306; UDI-DI:00630414589169, 00630414590851, 00630414590868, & 00630414590844; All Units and Software Versions.
12,363 units
Based on the official FDA remedy
What to do — step by step
Check Device Model
Identify the model number on the RAPIDPOINT 500 Blood Gas System to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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,…” 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-0423-2024 (September 26, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0423-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.