RAPIDPOINT 500 Blood Gas System
Reported: December 6, 2023 Initiated: September 26, 2023 #Z-0423-2024
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics Inc
- Units Affected
- 12,363 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, 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.
- Location
- Norwood, MA
Frequently Asked Questions
What product was recalled? ▼
RAPIDPOINT 500 Blood Gas System. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 12,363 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 6, 2023. Severity: Moderate. Recall number: Z-0423-2024.
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