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
Enforcement
- Recall Number
- Z-0608-2024
- Event ID
- 93473
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 27, 2023
- Initiation Date
- October 26, 2023
- Classification Date
- December 21, 2023
- Address
- 2 Edgewater Dr, N/A, Norwood, MA, 02062-4637, United States
Description
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
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.
UDI-DI: 00630414589763 All serial numbers
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
6611 cartridges US