RecallWatchUSA

Home / Recalls / Medical Devices

Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to

Recalled December 27, 2023 · FDA recall Z-0607-2024 · Siemens Healthcare Diagnostics

Hazard
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. · FDA Class II
Units
6035 cartridges US
Sold at
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

Description

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.

Product
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
Manufacturer(s)
Siemens Healthcare Diagnostics Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →